Label: LINCOMYCIN- lincomycin hydrochloride injection, solution

  • NDC Code(s): 39822-0350-1, 39822-0350-2, 39822-0353-6
  • Packager: X-GEN Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 12, 2019

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  • BOXED WARNING(What is this?)

    WARNING

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Lincomycin and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

    Because lincomycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.

    C.diffficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

    If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

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  • SPL UNCLASSIFIED SECTION

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

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  • DESCRIPTION

    Lincomycin Injection is a sterile solution which contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C18H34N2O6S.HCl.H2O and the molecular weight is 461.01.

    The structural formula is represented below:

    Chemical Structure

    Chemical Structure

    Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone.

    Each mL contains Lincomycin hydrochloride equivalent to 300 mg lincomycin. Also contains 9.45 mg benzyl alcohol added as a preservative.

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  • CLINICAL PHARMACOLOGY

    Intramuscular administration of a single dose of 600 mg of lincomycin produces average peak serum levels of 11.6 µg/mL at 60 minutes and maintains therapeutic levels for 17 to 20 hours for most susceptible gram-positive organisms. Urinary excretion after this dose ranges from 1.8 to 24.8 percent (mean: 17.3 percent).

    A two hour intravenous infusion of 600 mg of lincomycin achieves average peak serum levels of 15.9 µg/mL and yields therapeutic levels for 14 hours for most susceptible gram-positive organisms. Urinary excretion ranges from 4.9 to 30.3 percent (mean: 13.8 percent).

    The biological half-life after intramuscular or intravenous administration is 5.4 ± 1.0 hours. The serum half-life of lincomycin may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function. In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function. Hemodialysis and peritoneal dialysis are not effective in removing lincomycin from the serum.

    Tissue level studies indicate that bile is an important route of excretion. Significant levels have been demonstrated in the majority of body tissues. Although lincomycin appears to diffuse into cerebrospinal fluid (CSF), levels of lincomycin in the CSF appear inadequate for the treatment of meningitis.

    Microbiology

    Mechanism of Action

    Lincomycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the bacterial ribosome. Lincomycin is predominantly bacteriostatic in vitro.

    Resistance 
    Cross resistance has been demonstrated between clindamycin and lincomycin. Resistance is most often due to methylation of specific nucleotides in the 23S RNA of the 50S ribosomal subunit, which can determine cross resistance to macrolides and streptogramins B (MLS phenotype). Macrolide-resistant isolates of these organisms should be tested for inducible resistance to lincomycin/clindamycin using the D-zone test or other appropriate method.

    Antimicrobial Activity

    Lincomycin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections: (see INDICATIONS AND USAGE).
     Staphylococcus aureus
     Streptococcus pneumoniae

    The following in vitro data are available; but their clinical significance is unknown.

    Lincomycin has been shown to be active in vitro against the following microorganisms; however, the safety and efficacy of Lincomycin in treating clinical infections due to these organisms have not been established in adequate and well controlled trials.

    Gram-positive bacteria::
     Corynebacterium diphtheriae
     Streptococcus pyogenes

     Viridans group streptococci

    Anaerobic bacteria:
      Clostridium tetani
      Clostridium perfringens

    Susceptibility Testing

    For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC. 

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  • INDICATIONS AND USAGE

    Lincomycin Injection, USP is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibacterial associated pseudomembranous colitis, as described in the BOXED WARNING before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives.

    Indicated surgical procedures should be performed in conjunction with antibacterial therapy.

    The drug may be administered concomitantly with other antimicrobial agents when indicated.

    Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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  • CONTRAINDICATIONS

    This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.

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  • WARNINGS

    See BOXED WARNING. 

    Clostridium difficile associated diarrhea

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Lincomycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

    C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

    If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

    Hypersensitivity

    Severe hypersensitivity reactions, including anaphylactic reactions and severe cutaneous adverse reactions (SCAR) such as StevensJohnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and erythema multiforme (EM) have been reported in patients receiving Lincomycin Injection, USP therapy. If an anaphylactic reaction or severe skin reaction occurs, Lincomycin Injection, USP should be discontinued and appropriate therapy should be initiated. (See ADVERSE REACTIONS)

    Benzyl Alcohol Toxicity in Pediatric Patients (Gasping Syndrome)

    This product contains benzyl alcohol as a preservative.

    The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.

    Use in Meningitis — Although lincomycin appears to diffuse into cerebrospinal fluid, levels of lincomycin in the CSF may be inadequate for the treatment of meningitis.

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  • PRECAUTIONS

    General

    Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When Lincomycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.

    Lincomycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

    Lincomycin should be used with caution in patients with a history of asthma or significant allergies.

    Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibacterial therapy.

    The use of Lincomycin may result in overgrowth of nonsusceptible organisms— particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When patients with pre-existing monilial infections require therapy with Lincomycin, concomitant antimonilial treatment should be given.

    The serum half-life of lincomycin may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function. In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function.

    Patients with severe impairment of renal function and/or abnormal hepatic function should be dosed with caution and serum lincomycin levels monitored during high-dose therapy. (See DOSAGE AND ADMINISTRATION Section.)

    Lincomycin should not be injected intravenously undiluted as a bolus, but should be infused over at least 60 minutes as directed in the DOSAGE AND ADMINISTRATION Section.

    Prescribing Lincomycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

    Information for Patients

    Patients should be counseled that antibacterial drugs including Lincomycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Lincomycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Lincomycin or other antibacterial drugs in the future.

    Diarrhea is a common problem caused by antibacterial which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterial, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible

    Laboratory Tests

    During prolonged therapy with Lincomycin, periodic liver and kidney function tests and blood counts should be performed.

    Drug Interactions

    Lincomycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used in caution in patients receiving such agents.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    The carcinogenic potential of lincomycin has not been evaluated.

    Lincomycin was not found to be mutagenic in the Ames Salmonella reversion assay or the V79 Chinese hamster lung cells at the HGPRT locus. It did not induce DNA strand breaks in V79 Chinese hamster lung cells as measured by alkaline elution or chromosomal abnormalities in cultured human lymphocytes. In vivo, lincomycin was negative in both the rat and mouse micronucleus assays and it did not induce sex-linked recessive lethal mutations in the offspring of male Drosophila. However, lincomycin did cause unscheduled DNA syntheses in freshly isolated rat hepatocytes.

    Impairment of fertility was not observed in male or female rats given oral 300 mg/kg doses of lincomycin (0.36 times the highest recommended human dose based on mg/m2).

    Pregnancy

    There are no adequate and well-controlled studies in pregnant women. Lincomycin Injection, USP Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta. See WARNINGS. Lincomycin Injection, USP should be used during pregnancy only if clearly needed.

    Teratogenic Effects 

    In a study with 60 pregnant women, cord serum concentrations were approximately 25% of the maternal serum concentrations, indicating that lincomycin crosses the placenta, and no substantial accumulation occurred in the amniotic fluid. Experience with 345 obstetrical patients receiving Lincomycin Injection, USP revealed no ill effects related to pregnancy. 

    There was no evidence of teratogenicity when lincomycin was administered in diet to pregnant Sprague Dawley rats during the period of major organogenesis at doses up to 5000 mg/kg (approximately 6 times the maximum recommended human dose [MRHD], respectively, based on body surface area comparison).

    Nonteratogenic Effects

    Reproduction studies performed in rats administered oral lincomycin in diet for 2 weeks prior to mating, throughout pregnancy and lactation, revealed no adverse effects on survival of offspring from birth to weaning at doses up to 1000 mg/kg (1.2 times the MRHD based on body surface area comparison) up to 2 generations. 

    Nursing Mothers

    Lincomycin has been reported to appear in human milk in concentrations of 0.5 to 2.4 mcg/mL. Because of the potential for serious adverse reactions in nursing infants from Lincomycin, 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.

    Pediatric Use

    Lincomycin Injection, USP  contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants. See WARNINGS. Safety and effectiveness in pediatric patients below the age of one month have not been established. (See DOSAGE AND ADMINISTRATION Section.)

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  • ADVERSE REACTIONS

    The following reactions have been reported with the use of lincomycin:

    Gastrointestinal disorders

    Diarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfort1 , anal pruritus

    1 Event has been reported with intravenous injection.

    Skin and subcutaneous tissue disorders

    Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis,dermatitis bullous, dermatitis exfoliative, erythema multiforme (see WARNINGS), rash, urticaria, pruritus

    Infections and infestations

    Vaginal infection, pseudomembranous colitis, Clostridium difficile colitis (see Vaginal infection, pseudomembranous colitis, Clostridium diffi cile colitis (see WARNINGS))

    Blood and lymphatic system disorders

    Pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura 

    Immune system disorders

    Anaphylactic reaction (see WARNINGS), angioedema, serum sickness

    Hepatobiliary disorders

    Jaundice, liver function test abnormal, transaminases increased

    Renal and urinary disorders

    Renal impairment, oliguria, proteinuria, azotemia

    Cardiac disorders

    Cardio-respiratory arrest (see DOSAGE AND ADMINISTRATION)

    Vascular disorders

    Hypotension (see DOSAGE AND ADMINISTRATION), thrombophlebitis1

    Ear and labyrinth disorders

    Vertigo, tinnitus

    Neurologic disorders

    Headache, dizziness, somnolence

    General disorders and administration site conditions

    Injection site abscess sterile2 , injection site induration2 , injection site pain2 , injection site irritation2

    2Reported with intramuscular injection

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  • OVERDOSAGE

    Serum concentrations of lincomycin are not appreciably affected by hemodialysis and peritoneal dialysis.

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  • DOSAGE AND ADMINISTRATION

    If significant diarrhea occurs during therapy, this antibacterial should be discontinued. (See BOXED WARNING)

    INTRAMUSCULAR

    Adults

    Serious infections—600 mg (2 mL) intramuscularly every 24 hours. More severe infections—600 mg (2 mL) intramuscularly every 12 hours or more often.

    Pediatric patients over 1 month of age: Serious infections—one intramuscular injection of 10 mg/kg (5 mg/lb) every 24 hours. More severe infections—one intramuscular injection of 10 mg/kg (5 mg/lb) every 12 hours or more often. 

    INTRAVENOUS

    Adults:

    The intravenous dose will be determined by the severity of the infection. For serious infections doses of 600 mg of lincomycin (2 mL of Lincomycin Injection) to 1 gram are given every 8 to 12 hours. For more severe infections these doses may have to be increased. In life-threatening situations, daily intravenous doses of as much as 8 grams have been given. Intravenous doses are given on the basis of 1 gram of lincomycin diluted in not less than 100 mL of appropriate solution (see PHYSICAL COMPATIBILITIES) and infused over a period of not less than one hour.

     Dose  Vol. Diluent Time

    600 mg 100 mL 1 hr

    1 gram 100 mL 1 hr

    2 grams 200 mL 2 hr

    3 grams 300 mL 3 hr

    4 grams 400 mL 4 hr

    These doses may be repeated as often as required to the limit of the maximum recommended daily dose of 8 grams of lincomycin. Pediatric patients over 1 month of age 10 to 20 mg/kg/day (5 to 10 mg/lb/day) depending on the severity of the infection may be infused in divided doses as described above for adults.

    NOTE: Severe cardiopulmonary reactions have occurred when this drug has been given at greater than the recommended concentration and rate.

    SUBCONJUNCTIVAL INJECTION

    0.25 mL (75 mg) injected subconjunctivally will result in ocular fluid levels of antibacterial (lasting for at least 5 hours) with MICs sufficient for most susceptible pathogens.

    Patients with diminished renal function 

    When therapy with Lincomycin is required in individuals with severe impairment of renal function, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys.

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  • HOW SUPPLIED

    Lincomycin Injection, USP is available in the following strength and package sizes:

    300 mg/mL

    2 mL Vials — NDC 39822-0350-1 Packaged as 10 vials per carton NDC 39822-0350-2

    10 mL Vials — NDC 39822-0353-5 Packaged as 10 vials per carton NDC 39822-0353-6

     Each mL of Lincomycin Injection, USP contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative. 

    Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

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  • ANIMAL PHARMACOLOGY

    In vivo experimental animal studies demonstrated the effectiveness of LINCOCIN preparations (lincomycin) in protecting animals infected with Streptococcus viridans,β-hemolytic Streptococcus, Staphylococcus aureus, Diplococcus pneumoniae and Leptospira pomona. It was ineffective in Klebsiella, Pasteurella, Pseudomonas, Salmonella and Shigella infections.

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  • PHYSICAL COMPATIBILITIES

    Physically compatible for 24 hours at room temperature unless otherwise indicated.

    Infusion Solutions
    5% Dextrose Injection
    10% Dextrose Injection
    5% Dextrose and 0.9% Sodium Chloride Injection
    10% Dextrose and 0.9% Sodium Chloride Injection
    Ringer's Injection

    1/6 M Sodium Lactate Injection

    Travert 10%-Electrolyte No. 1
    Dextran in Saline 6% w/v

    Vitamins in Infusion Solutions
    B-Complex
    B-Complex with Ascorbic Acid

    Antibacterial in Infusion Solutions
    Penicillin G Sodium (Satisfactory for 4 hours)
    Cephalothin
    Tetracycline HCl
    Cephaloridine
    Colistimethate (Satisfactory for 4 hours)
    Ampicillin
    Methicillin
    Chloramphenicol
    Polymyxin B Sulfate

    Physically Incompatible with:
    Novobiocin
    Kanamycin

    IT SHOULD BE EMPHASIZED THAT THE COMPATIBLE AND INCOMPATIBLE DETERMINATIONS ARE PHYSICAL OBSERVATIONS ONLY, NOT CHEMICAL DETERMINATIONS. ADEQUATE CLINICAL EVALUATION OF THE SAFETY AND EFFICACY OF THESE COMBINATIONS HAS NOT BEEN PERFORMED.

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  • SPL UNCLASSIFIED SECTION

    Rx only

    Manufactured in Germany

    Manufactured for:

    X-GEN Pharmaceuticals, Inc.

    Big Flats, NY 14814

    March 2019

    LC-PI-11

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  • PRINCIPAL DISPLAY PANEL - 1-2 mL Vial Label

    X-GEN Pharmaceuticals, Inc.

    NDC 39822-0350-1

    lincomycin injection, USP

    300 mg/mL

    1-2 mL Vial
    Rx only

     

    2 ml label

    2 ml label


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  • PRINCIPAL DISPLAY PANEL - 1-10 mL Vial Label

    X-GEN Pharmaceuticals, Inc.

    NDC 39822-0353-5

    lincomycin injection, USP

    300 mg/mL

    1-10 mL Vial
    Rx only

    linco-10ml-vial

    linco-10ml-vial

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  • INGREDIENTS AND APPEARANCE
    LINCOMYCIN 
    lincomycin hydrochloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39822-0350
    Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCONJUNCTIVAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN 300 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:39822-0350-2 10 in 1 CARTON 07/05/2015
    1 NDC:39822-0350-1 2 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA201746 07/05/2015
    LINCOMYCIN 
    lincomycin hydrochloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39822-0353
    Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCONJUNCTIVAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN 300 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:39822-0353-6 10 mL in 1 VIAL; Type 0: Not a Combination Product 07/05/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA201746 07/05/2015
    Labeler - X-GEN Pharmaceuticals, Inc. (790169531)
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