NDC 68382-533

minocycline hydrochloride

Minocycline Hydrochloride

minocycline hydrochloride is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Minocycline Hydrochloride.

Product ID68382-533_477e14da-fb39-4e5d-acec-2f07ee55aaba
NDC68382-533
Product TypeHuman Prescription Drug
Proprietary Nameminocycline hydrochloride
Generic NameMinocycline Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-03-07
Marketing CategoryANDA / ANDA
Application NumberANDA203553
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameMINOCYCLINE HYDROCHLORIDE
Active Ingredient Strength90 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-533-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-533-01)
Marketing Start Date2018-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-533-30 [68382053330]

minocycline hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203553
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68382-533-16 [68382053316]

minocycline hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203553
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68382-533-05 [68382053305]

minocycline hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203553
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68382-533-06 [68382053306]

minocycline hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203553
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68382-533-10 [68382053310]

minocycline hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203553
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68382-533-01 [68382053301]

minocycline hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203553
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

Drug Details

Active Ingredients

IngredientStrength
MINOCYCLINE HYDROCHLORIDE90 mg/1

OpenFDA Data

SPL SET ID:85f082a5-bba1-4441-ba28-4b8ec9a537f2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1013665
  • 629695
  • 629697
  • 629699
  • 1013659

    • 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.