NDC 0115-9935

minocycline hydrochloride

Minocycline Hydrochloride

minocycline hydrochloride is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York, Llc. The primary component is Minocycline Hydrochloride.

Product ID0115-9935_229765ad-c63d-4aee-a2ce-bc4f5e01e282
NDC0115-9935
Product TypeHuman Prescription Drug
Proprietary Nameminocycline hydrochloride
Generic NameMinocycline Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-07-23
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA050808
Labeler NameAmneal Pharmaceuticals of New York, LLC
Substance NameMINOCYCLINE HYDROCHLORIDE
Active Ingredient Strength65 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0115-9935-08

1 BOTTLE in 1 CARTON (0115-9935-08) > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2009-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-9935-08 [00115993508]

minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA050808
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-23

Drug Details

Active Ingredients

IngredientStrength
MINOCYCLINE HYDROCHLORIDE65 mg/1

OpenFDA Data

SPL SET ID:65351e02-ba65-4ae9-a131-f8c99b9401b8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 858372
  • 858062
  • UPC Code
  • 0301159935084
  • Pharmacological Class

    • Tetracycline-class Drug [EPC]
    • Tetracyclines [CS]

    NDC Crossover Matching brand name "minocycline hydrochloride" or generic name "Minocycline Hydrochloride"

    NDCBrand NameGeneric Name
    0093-2133Minocycline HydrochlorideMinocycline Hydrochloride
    0093-2134Minocycline HydrochlorideMinocycline Hydrochloride
    0093-7741Minocycline HydrochlorideMinocycline Hydrochloride
    0093-7742Minocycline HydrochlorideMinocycline Hydrochloride
    0093-7743Minocycline HydrochlorideMinocycline Hydrochloride
    0115-9935minocycline hydrochlorideminocycline hydrochloride
    0115-9936minocycline hydrochlorideminocycline hydrochloride
    0378-4293Minocycline Hydrochlorideminocycline hydrochloride
    0378-4294Minocycline Hydrochlorideminocycline hydrochloride
    0440-7805Minocycline hydrochlorideMinocycline hydrochloride
    0591-3153Minocycline HydrochlorideMinocycline Hydrochloride
    0591-5694Minocycline HydrochlorideMinocycline Hydrochloride
    0591-5695Minocycline HydrochlorideMinocycline Hydrochloride
    0781-5385Minocycline HydrochlorideMinocycline Hydrochloride
    0781-5386Minocycline HydrochlorideMinocycline Hydrochloride
    0781-5387Minocycline HydrochlorideMinocycline Hydrochloride
    0904-6888Minocycline HydrochlorideMinocycline Hydrochloride
    13668-482Minocycline HydrochlorideMinocycline Hydrochloride
    67877-438Minocycline HydrochlorideMinocycline Hydrochloride
    67877-576Minocycline HydrochlorideMinocycline Hydrochloride
    67877-578Minocycline HydrochlorideMinocycline Hydrochloride
    67877-437Minocycline HydrochlorideMinocycline Hydrochloride
    67877-643Minocycline HydrochlorideMinocycline Hydrochloride
    67877-644Minocycline HydrochlorideMinocycline Hydrochloride
    67877-577Minocycline HydrochlorideMinocycline Hydrochloride
    68071-1937Minocycline HydrochlorideMinocycline Hydrochloride
    68071-3338Minocycline HydrochlorideMinocycline Hydrochloride
    68071-3307Minocycline HydrochlorideMinocycline Hydrochloride
    68071-4227Minocycline HydrochlorideMinocycline Hydrochloride
    68071-4163Minocycline HydrochlorideMinocycline Hydrochloride
    68071-4216Minocycline HydrochlorideMinocycline Hydrochloride
    68151-2299Minocycline HydrochlorideMinocycline Hydrochloride
    68180-381Minocycline HydrochlorideMinocycline Hydrochloride
    68180-380Minocycline HydrochlorideMinocycline Hydrochloride
    68180-379Minocycline HydrochlorideMinocycline Hydrochloride
    68180-460Minocycline HydrochlorideMinocycline Hydrochloride
    68382-535minocycline hydrochlorideminocycline hydrochloride
    68382-531minocycline hydrochlorideminocycline hydrochloride
    68382-316Minocycline hydrochlorideMinocycline hydrochloride
    68382-318Minocycline hydrochlorideMinocycline hydrochloride
    68382-533minocycline hydrochlorideminocycline hydrochloride
    68382-551minocycline hydrochlorideminocycline hydrochloride
    68382-317Minocycline hydrochlorideMinocycline hydrochloride
    68382-552minocycline hydrochlorideminocycline hydrochloride
    68682-467minocycline hydrochlorideminocycline hydrochloride
    68682-466minocycline hydrochlorideminocycline hydrochloride
    68682-468minocycline hydrochlorideminocycline hydrochloride
    68788-9085Minocycline hydrochlorideMinocycline hydrochloride
    68788-6997Minocycline HydrochlorideMinocycline Hydrochloride
    68788-7052Minocycline HydrochlorideMinocycline Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.