NDC 67877-577

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 Ascend Laboratories, Llc. The primary component is Minocycline Hydrochloride.

Product ID67877-577_1a259e4f-fadd-4307-abbd-da3fe3e83a3a
NDC67877-577
Product TypeHuman Prescription Drug
Proprietary NameMinocycline Hydrochloride
Generic NameMinocycline Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA204453
Labeler NameAscend Laboratories, LLC
Substance NameMINOCYCLINE HYDROCHLORIDE
Active Ingredient Strength135 mg/1
Pharm ClassesTetracycline-class Drug [EPC], Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 67877-577-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-577-01)
Marketing Start Date2016-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67877-577-14 [67877057714]

Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204453
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-30

NDC 67877-577-30 [67877057730]

Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204453
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-30

NDC 67877-577-01 [67877057701]

Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204453
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-30

NDC 67877-577-05 [67877057705]

Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204453
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-30

Drug Details

Active Ingredients

IngredientStrength
MINOCYCLINE HYDROCHLORIDE135 mg/1

OpenFDA Data

SPL SET ID:a8f95207-b259-4f50-87f2-3652d9268890
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 629699
  • 629695
  • 629697
  • 858372
  • 858062
  • 1013665
  • 1013659
  • UPC Code
  • 0367877437309
  • 0367877438306
  • 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.