NDC 65976-100

Arestin

Minocycline Hydrochloride

Arestin is a Oral Powder in the Human Prescription Drug category. It is labeled and distributed by Orapharma, Inc.. The primary component is Minocycline Hydrochloride.

Product ID65976-100_5dc9baca-d187-45a8-8c7a-68cdb5f9dbed
NDC65976-100
Product TypeHuman Prescription Drug
Proprietary NameArestin
Generic NameMinocycline Hydrochloride
Dosage FormPowder
Route of AdministrationORAL
Marketing Start Date2011-03-21
Marketing CategoryNDA / NDA
Application NumberNDA050781
Labeler NameOraPharma, Inc.
Substance NameMINOCYCLINE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65976-100-01

1 POWDER in 1 POUCH (65976-100-01)
Marketing Start Date2011-03-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65976-100-12 [65976010012]

Arestin POWDER
Marketing CategoryNDA
Application NumberNDA050781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-21

NDC 65976-100-24 [65976010024]

Arestin POWDER
Marketing CategoryNDA
Application NumberNDA050781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-21

NDC 65976-100-01 [65976010001]

Arestin POWDER
Marketing CategoryNDA
Application NumberNDA050781
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-03-21

Drug Details

Active Ingredients

IngredientStrength
MINOCYCLINE HYDROCHLORIDE1 mg/1

OpenFDA Data

SPL SET ID:8515df41-1936-4f3b-86ba-d2bb2a8441fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351974
  • 351121

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    65976-100ArestinArestin
    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 [Arestin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ARESTIN
    ARESTIN
    75883599 2601899 Live/Registered
    ORAPHARMA INC.
    1999-12-29
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