Label: DOXYCYCLINE capsule
DOXYCYCLINE MONOHYDRATE capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 14, 2019

If you are a consumer or patient please visit this version.

  • DESCRIPTION

  • CLINICAL PHARMACOLOGY

  • CLINICAL PHARMACOLOGY PART 2

  • INDICATIONS AND USAGE

  • CONTRAINDICATIONS

  • WARNINGS

  • PRECAUTIONS

  • ADVERSE REACTIONS

  • OVERDOSAGE

  • DOSAGE AND ADMINISTRATION

  • ANIMAL PHARMACOLOGY AND OR TOXICOLOGY

  • STORAGE AND HANDLING

  • HOW SUPPLIED

    Doxycycline Capsules USP, 50 mg are light yellow to yellow powder filled in hard gelatin capsule shell having an opaque yellow cap and an opaque white body printed with 782 on cap with black ink and are supplied as follows:

    NDC 68382-782-06 in bottle of 30 capsules

    NDC 68382-782-18 in bottle of 50 capsules

    NDC 68382-782-16 in bottle of 90 capsules

    NDC 68382-782-01 in bottle of 100 capsules

    NDC 68382-782-05 in bottle of 500 capsules

    NDC 68382-782-10 in bottle of 1000 capsules

    NDC 68382-782-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules

    Doxycycline Capsules USP, 75 mg are light yellow to yellow powder filled in hard gelatin capsule shells having an opaque orange cap and an opaque white body printed with 706 on cap in black ink and are supplied as follows:

    NDC 68382-706-06 in bottle of 30 capsules

    NDC 68382-706-18 in bottle of 50 capsules

    NDC 68382-706-16 in bottle of 90 capsules

    NDC 68382-706-01 in bottle of 100 capsules

    NDC 68382-706-05 in bottle of 500 capsules

    NDC 68382-706-10 in bottle of 1000 capsules

    NDC 68382-706-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules

    Doxycycline Capsules USP, 100 mg are light yellow to yellow powder filled in hard gelatin capsule shells having an opaque yellow cap and an opaque orange body printed with 707 on cap in black ink and are supplied as follows:

    NDC 68382-707-06 in bottle of 30 capsules

    NDC 68382-707-18 in bottle of 50 capsules

    NDC 68382-707-16 in bottle of 90 capsules

    NDC 68382-707-01 in bottle of 100 capsules

    NDC 68382-707-21 in bottle of 250 capsules

    NDC 68382-707-05 in bottle of 500 capsules

    NDC 68382-707-10 in bottle of 1000 capsules

    NDC 68382-707-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules

    Storage

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

    Dispense in a tight, light-resistant container as defined in the USP.

    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.

    Minocycline, 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.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Cadila Healthcare Limited

    Ahmedabad, India.

    Distributed by:

    Zydus Pharmaceuticals (USA) Inc.

    Pennington, NJ 08534

    Rev.: 02/18

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

  • REFERENCES

    Clinical and Laboratory Standards Institute (CLSI). Methods for Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard – Second Edition. CLSI document M24-A2 [2011], Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA.
    Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press: 2000: 149-195.
    Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997;89:524-528.
    Horne HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25:315-317.
    Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing 2000; 225-226.

    Please address medical inquiries to, MedicalAffairs@zydususa.com Tel.: 1-877-993-8779.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    DOXYCYCLINE MONOHYDRATE 100mg 20 CAPS

  • PRINCIPAL DISPLAY PANEL

    624-20

  • INGREDIENTS AND APPEARANCE
    DOXYCYCLINE 
    doxycycline capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-276(NDC:43386-792)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN (UNII: 2G86QN327L)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Coloryellow (Opaque Body) , brown (Opaque Cap) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code NL792;100mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-276-2020 in 1 BOTTLE; Type 0: Not a Combination Product03/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20444603/17/2016
    DOXYCYCLINE MONOHYDRATE 
    doxycycline monohydrate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-624(NDC:68382-707)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862) DOXYCYCLINE ANHYDROUS100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA (UNII: 5138Q19F1X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    Coloryellow (OPAQUE YELLOW) , orange (OPAQUE ORANGE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code 707
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-624-2020 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2019
    2NDC:61919-624-1414 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20511504/05/2019
    Labeler - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(61919-276, 61919-624)