NDC 54531-100

Minocin

Minocycline Hydrochloride

Minocin is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Rempex Pharmaceuticals, Inc. The primary component is Minocycline Hydrochloride.

Product ID54531-100_c0dda789-4173-431d-9d0a-8648da6e0c91
NDC54531-100
Product TypeHuman Prescription Drug
Proprietary NameMinocin
Generic NameMinocycline Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-04-19
Marketing CategoryNDA / NDA
Application NumberNDA050444
Labeler NameRempex Pharmaceuticals, Inc
Substance NameMINOCYCLINE HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 54531-100-01

10 INJECTION in 1 CARTON (54531-100-01)
Marketing Start Date2013-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54531-100-01 [54531010001]

Minocin INJECTION
Marketing CategoryNDA
Application NumberNDA050444
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-19
Marketing End Date2016-12-31
Inactivation Date2020-01-31
Reactivation Date2020-02-13

Drug Details

Active Ingredients

IngredientStrength
MINOCYCLINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:609de469-5f90-405b-85c9-0a39133b916e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317127
  • 207358

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Minocin" or generic name "Minocycline Hydrochloride"

    NDCBrand NameGeneric Name
    70842-160MinocinMinocin
    16781-403MinocinMinocin
    16781-400MinocinMinocin
    43353-172MinocinMinocin
    54531-100MinocinMinocin
    65293-014MinocinMinocin
    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
    10631-330Ximinominocycline hydrochloride
    10631-331Ximinominocycline hydrochloride
    10631-332Ximinominocycline hydrochloride

    Trademark Results [Minocin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MINOCIN
    MINOCIN
    72309825 0877677 Live/Registered
    AMERICAN CYANAMID COMPANY
    1968-10-17
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.