DOXYCYCLINE
-
doxycycline capsule
Sandoz Inc.
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Doxycycline Capsules USPDESCRIPTION
Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The chemical designation of the light-yellow crystalline powder is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12aoctahydro-3,5,10,-12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamidemonohydrate. The structural formula is:
C22H24N2O8• H2O M.W. = 462.46
Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline Capsules USP contain doxycycline monohydrate equivalent to 50 mg or 100 mg of doxycycline for oral administration. The capsules contain the following inactive ingredients: black iron oxide, n-butyl alcohol, colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, propylene glycol, red iron oxide, sodium starch glycolate, titanium dioxide, yellow iron oxide.
In addition, the 50 mg capsules contain alcohol and lecithin; and the 100 mg capsules contain ammonium hydroxide, isopropyl alcohol, and simethicone.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.
Following a 200 mg dose of doxycycline monohydrate, 24 normal adult volunteers averaged the following serum concentration values:
| Time (hr): | 0.5 | 1.0 | 1.5 | 2.0 | 3.0 | 4.0 | 8.0 | 12.0 | 24.0 | 48.0 | 72.0 |
| Conc. (mcg/mL) | 1.02 | 2.26 | 2.67 | 3.01 | 3.16 | 3.03 | 2.03 | 1.62 | 0.95 | 0.37 | 0.15 |
| Average Observed Values | |
| Maximum Concentration | 3.61 mcg/mL (± 0.9 sd) |
| Time of Maximum Concentration | 2.60 hr (± 1.10 sd) |
| Elimination Rate Constant | 0.049 per hr (± 0.030 sd) |
| Half-Life | 16.33 hr (± 4.53 sd) |
Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min). This percentage excretion may fall as low as 1-5%/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 mL/min). Studies have shown no significant difference in serum half-life of doxycycline (range 18-22 hours) in individuals with normal and severely impaired renal function.
Hemodialysis does not alter serum half-life.
Microbiology: The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gramnegative organisms. Cross-resistance of these organisms to tetracyclines is common.
While in vitro studies have demonstrated the susceptibility of most strains of the following microorganisms, clinical efficacy for infections other than those included in the INDICATIONS AND USAGE section has not been documented.
GRAM-NEGATIVE BACTERIA:
- Neisseria gonorrhoeae
- Haemophilus ducreyi
- Haemophilus influenzae
- Yersinia pestis (formerly Pasteurella pestis)
- Francisellea tularensis (formerly Pasteurella tularensis)
- Vibrio cholerae (formerly Vibrio comma)
- Bartonella bacilliformis
- Brucella species
Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended:
- Escherichia coli
- Klebsiella species
- Enterobacter aerogenes
- Shigella species
- Acinetobacter species (formerly Mima species and Hereilea species)
- Bacteroides species
GRAM-POSITIVE BACTERIA:
Because many strains of the following groups of gram-positive microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended. Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used to treat streptococcal infections unless the organism has been demonstrated to be susceptible.
- Streptococcus pyogenes
- Streptococcus pneumoniae
- Enterococcus group (Streptococcus faecalis and Streptococcus faecium)
- Alpha-hemolytic Streptococci (Viridans group)
OTHER MICROORGANISMS:
- Chlamydia psittaci
- Chlamydia trachomatis
- Ureaplasma urealyticum
- Borrelia recurrentis
- Treponema pallidum
- Treponema pertenue
- Clostridium species
- Fusobacterium fusiforme
- Actinomyces species
- Bacillus anthracis
- Propionibacterium acnes
- Entamoeba species
- Balantidium coli
Susceptibility tests:
DIFFUSION TECHNIQUES:
Quantitative methods that require measurement of zone diameters give the most precise estimate of the susceptibility of bacteria to antimicrobial agents.
One such standard procedure1 which has been recommended for use with disks to test susceptibility of organisms to doxycycline uses the 30-mcg tetracycline-class disk or the 30-mcg doxycycline disk. Interpretation involves the correlation of the diameter obtained in the disk test with the minimum inhibitory concentration (MIC) for tetracycline or doxycycline, respectively.
Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30- mcg tetracycline-class disk or the 30-mcg doxycycline disk should be interpreted according to the following criteria:
| Zone Diameter (mm) | Interpretation | |
| tetracycline | doxycycline | |
| ≥19 | ≥16 | Susceptible |
| 15-18 | 13-15 | Intermediate |
| ≤14 | ≤12 | Resistant |
A report of “susceptible” indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of “intermediate” suggests that the organism would be susceptible if a high dosage is used or if the infection is confined to tissues and fluids in which high antimicrobial levels are attained. A report of “resistant” indicates that achievable concentrations are unlikely to be inhibitory, and other therapy should be selected.
Standardized procedures require the use of laboratory control organisms. The 30-mcg tetracyclineclass disk or the 30-mcg doxycycline disk should give the following zone diameters:
| Organism | Zone Diameter | |
| tetracycline | doxycycline | |
| E. coli ATCC 25922 | 18-25 | 18-24 |
| S. aureus ATCC 25923 | 19-28 | 23-29 |
DILUTION TECHNIQUES:
Use a standardized dilution method2 (broth, agar, microdilution) or equivalent with tetracycline powder. The MIC values obtained should be interpreted according to the following criteria:
| MIC (mcg/mL) | Interpretation |
| ≤4 | Susceptible |
| 8 | Intermediate |
| ≥16 | Resistant |
As with standard diffusion techniques, dilution methods require the use of laboratory control organisms. Standard tetracycline powder should provide the following MIC values:
| Organism |
MIC (mcg/mL) |
| S. aureus ATCC 29213 | 0.25-1 |
| E. faecalis ATCC 29212 | 8-32 |
| E. coli ATCC 25922 | 1-4 |
| P. aeruginosa ATCC 27853 | 8-32 |
INDICATIONS AND USAGE
Doxycycline is indicated for the treatment of the following infections:
- Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.
- Respiratory tract infections caused by Mycoplasma pneumoniae.
- Lymphogranuloma venereum caused by Chlamydia trachomatis.
- Psittacosis (ornithosis) caused by Chlamydia psittaci.
- Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.
- Inclusion conjunctivitis caused by Chlamydia trachomatis.
- Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.
- Nongonococcal urethritis caused by Ureaplasma urealyticum.
- Relapsing fever due to Borrelia recurrentis.
Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:
- Chancroid caused by Haemophilus ducreyi.
- Plague due to Yersinia pestis (formerly Pasteurella pestis).
- Tularemia due to Francisella tularensis (formerly Pasteurella tularensis).
- Cholera caused by Vibrio cholerae (formerly Vibrio comma).
- Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus).
- Brucellosis due to Brucella species (in conjunction with streptomycin).
- Bartonellosis due to Bartonella bacilliformis.
- Granuloma inguinale caused by Calymmatobacterium granulomatis.
Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibilty testing are recommended.
Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
- Escherichia coli
- Enterobacter aerogenes (formerly Aerobacter aerogenes)
- Shigella species
- Acinetobacter species (formerly Mima species and Herellea species)
- Respiratory tract infections caused by Haemophilus influenzae
- Respiratory tract and urinary tract infections caused by Klebsiella species
Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
- Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).
- Skin and skin structure infections caused by Staphylococcus aureus.
Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infections.
Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:
- Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
- Syphillis caused by Treponema pallidum.
- Yaws caused by Treponema pertenue.
- Listeriosis due to Listeria monocytogenes.
- Vincent’s infection caused by Fusobacterium fusiforme.
- Actinomycosis caused by Actinomyces israelii.
- Infections caused by Clostridium species.
In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.
In severe acne, doxycycline may be useful adjunctive therapy.
CONTRAINDICATIONS
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
WARNINGS
THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including doxycycline, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.”
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryo toxicity has been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus.
The antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patient apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
PRECAUTIONS
General
As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.
Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued.
Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.
Laboratory Tests
In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months.
In long-term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.
Drug Interactions
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.
Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
Concurrent use of tetracycline may render oral contraceptives less effective.
Drug/Laboratory Test Interactions
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate the carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with related antibiotics, oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors). Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in vitro mammalian cell assays have been reported for related antibiotics (tetracycline, oxytetracycline). Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on the fertility of female rats. Effect on male fertility has not been studied.
Pregnancy
Teratogenic Effects
Pregnancy Category D
There are no adequate and well-controlled studies on the use of doxycycline in pregnant short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women such as that proposed for treatment of anthrax exposure. An expert review of published data on experiences with doxycycline use during pregnancy by TERIS - the Teratogen Information System - concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the data are insufficient to state there is no risk3.
A case-control study (18,515 mothers of infants with congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statistically significant association with total malformations and use of doxycycline anytime during pregnancy. (Sixty-three (0.19%) of the controls and 56 (0.30%) of the cases were treated with doxycycline.) This association was not seen when the analysis was confined to maternal treatment during the period of organogenesis (i.e., in the second and third months of gestation) with the exception of a marginal relationship with neural tube defect based on only two exposed cases4.
A small prospective study of 81 pregnancies describes 43 pregnant women treated for 10 days with doxycycline during early first trimester. All mothers reported their exposed infants were normal at 1 year of age5.
Labor and Delivery
The effect of tetracyclines on labor and delivery is unknown.
Nursing Mothers
Tetracyclines are excreted in human milk, however, the extent of absorption of tetracyclines, including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated; however, the effects of prolonged exposure to doxycycline in breast milk are unknown6. Because of the potential for adverse reactions in nursing infants from doxycycline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. (See WARNINGS.)
Pediatric Use
See WARNINGS and DOSAGE AND ADMINISTRATION sections.
ADVERSE REACTIONS
Due to oral doxycycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.
Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See DOSAGE AND ADMINISTRATION.)
Skin: Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS.)
Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS.)
Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, and exacerbation of systemic lupus erythematosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported with tetracyclines.
Other: Bulging fontanels in infants and intracranial hypertension in adults. (See PRECAUTIONS, General.)
When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. No abnormalities of thyroid function are known to occur.
OVERDOSAGE
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life, and it would not be of benefit in treating cases of overdosage.
DOSAGE AND ADMINISTRATION
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours or 50 mg every 6 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For pediatric patients above eight years of age: The recommended dosage schedule for pediatric patients weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For pediatric patients over 100 pounds the usual adult dose should be used.
Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.
Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.
Primary and secondary syphilis: 300 mg a day in divided doses for at least 10 days.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth, twice a day for at least 7 days.
Nongonococcal urethritis caused by C. trachomatis and U. urealyticum: 100 mg, by mouth, twice a day for at least 7 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.
When used in streptococcal infections, therapy should be continued for 10 days.
Inhalational anthrax (post-exposure): ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.
Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS). If gastric irritation occurs, doxycycline may be given with food. Ingestion of a high fat meal has been shown to delay the time to peak plasma concentrations by an average of one hour and 20 minutes. However, in the same study, food enhanced the average peak concentration by 7.5% and the area under the curve by 5.7%.
HOW SUPPLIED
Doxycycline Capsules USP, 50 mg have a rich yellow opaque cap and body, imprinted with “E 805” in brown ink on cap and body. Each capsule contains doxycycline monohydrate equivalent to 50 mg doxycycline. Doxycycline Capsules USP, 50 mg is available in bottles of 100 and 500.
Doxycycline Capsules USP, 100 mg have a brown opaque cap and body, imprinted with “E 810” in white ink on cap and body. Each capsule contains doxycycline monohydrate equivalent to 100 mg doxycycline. Doxycycline Capsules USP, 100 mg is available in bottles of 50, 100, 250 and 500.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
PROTECT FROM LIGHT.
ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY
Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4, and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.
Minocycyline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.
Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: In rats and dogs (minocycline), in chickens (chlortetracycline) and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.
REFERENCES
1. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests, Fourth Edition. Approved Standard NCCLS Document M2-A4, Vol. 10, No. 7 NCCLS, Villanova, PA, April 1990.
2. National Committee for Clinical Laboratory Standards, Methods for Dilution Animicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Second Edition. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8 NCCLS, Villanova, PA, April 1990.
3. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press: 2000: 149-195.
4. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997;89: 524-528.
5. Horne HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25:315-317.
6. Hale T. Medications and Mothers Milk. 9th. edition. Amarillo, TX: Pharmasoft Publishing 2000; 225-226.
Sandoz Inc.
Princeton, NJ 08540
Rev. 06/06
MF0805REV06/06
OS7603
MG #14760
Doxycycline Capsules USP, 50 mg x 500 Capsules - Label
NDC 0185-0805-05
Doxycycline Capsules USP
50 mg
Rx only
500 Capsules
Sandoz
Doxycycline Capsules USP, 100 mg x 50 Capsules - Label
NDC 0185-0810-53
Doxycycline Capsules USP
100 mg
Rx only
50 Capsules
Sandoz
| DOXYCYCLINE
doxycycline capsule |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA065032 | 06/30/2000 | |
| DOXYCYCLINE
doxycycline capsule |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA065032 | 06/30/2000 | |
| Labeler - Sandoz Inc. (614842560) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sandoz Inc | 614842560 | RELABEL, REPACK, MANUFACTURE, ANALYSIS | |