NDC 0378-4294

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 Mylan Pharmaceuticals Inc.. The primary component is Minocycline Hydrochloride.

Product ID0378-4294_25fd6eb2-0922-46f4-85c5-04c35e1bbc19
NDC0378-4294
Product TypeHuman Prescription Drug
Proprietary NameMinocycline Hydrochloride
Generic NameMinocycline Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-02-22
Marketing CategoryANDA / ANDA
Application NumberANDA203443
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMINOCYCLINE HYDROCHLORIDE
Active Ingredient Strength105 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-4294-93

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4294-93)
Marketing Start Date2019-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4294-93 [00378429493]

Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203443
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-22
Marketing End Date2020-11-30

Drug Details

Active Ingredients

IngredientStrength
MINOCYCLINE HYDROCHLORIDE105 mg/1

OpenFDA Data

SPL SET ID:6d7bdd2e-44ff-4dc4-b164-e88c30c80308
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1013665
  • 1013659
    • UPC Code
  • 0303784293935
  • 0303784294932

    • 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
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