NDC 10135-612

Niacin

Niacin

Niacin is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Niacin.

Product ID10135-612_33e9a963-426b-48fe-ac2a-34ec6e2151bd
NDC10135-612
Product TypeHuman Prescription Drug
Proprietary NameNiacin
Generic NameNiacin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA203578
Labeler NameMarlex Pharmaceuticals Inc
Substance NameNIACIN
Active Ingredient Strength500 mg/1
Pharm ClassesNicotinic Acid [EPC],Nicotinic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10135-612-90

90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10135-612-90)
Marketing Start Date2016-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-612-90 [10135061290]

Niacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-01
Inactivation Date2020-01-31

NDC 10135-612-05 [10135061205]

Niacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203578
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-01
Inactivation Date2020-01-31

NDC 10135-612-30 [10135061230]

Niacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203578
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NIACIN500 mg/1

OpenFDA Data

SPL SET ID:e80aadb4-0533-4887-8dbb-a75f0c739942
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098141
  • 1098143
  • 1098134
  • Pharmacological Class

    • Nicotinic Acid [EPC]
    • Nicotinic Acids [CS]

    NDC Crossover Matching brand name "Niacin" or generic name "Niacin"

    NDCBrand NameGeneric Name
    10135-612NiacinNiacin
    10135-613NiacinNiacin
    10135-614NiacinNiacin
    33342-187NiacinNiacin
    33342-189NiacinNiacin
    42291-584NiacinNiacin
    42291-586NiacinNiacin
    47335-539NIACINNIACIN
    47335-613NIACINNIACIN
    47335-614NIACINNIACIN
    50268-584NiacinNiacin
    50268-586NiacinNiacin
    51407-116NIACINNIACIN
    68084-756NIACINNIACIN
    68084-773NIACINNIACIN
    68151-6840NiacinNiacin
    68180-221NIACINNIACIN
    68180-223NIACINNIACIN
    68180-222NIACINNIACIN
    68382-203NiacinNiacin
    68382-201NiacinNiacin
    51407-117NIACINNIACIN
    51407-118NIACINNIACIN
    57297-222NIACINNIACIN
    57297-223NIACINNIACIN
    57297-221NIACINNIACIN
    59651-019NiacinNiacin
    59651-020NiacinNiacin
    59746-387niacinniacin
    59746-381niacinniacin
    59651-018NiacinNiacin
    59746-380niacinniacin
    62175-320NiacinNiacin
    62175-322NiacinNiacin
    63629-7193NIACINNIACIN
    65162-321NiacinNiacin
    65162-323NiacinNiacin
    65162-322NiacinNiacin
    71741-047NIACINNIACIN
    51407-268NiacinNiacin
    51407-267NiacinNiacin
    0245-0067NiacorNiacin
    0074-3265NiaspanNiacin
    0074-3274NiaspanNiacin
    0074-3275NiaspanNiacin
    21695-852NiaspanNiacin
    21695-865NiaspanNiacin
    50090-1536NiaspanNiacin

    Trademark Results [Niacin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NIACIN
    NIACIN
    85884244 4418663 Live/Registered
    Lonza AG (Lonza Ltd.)
    2013-03-22
    NIACIN
    NIACIN
    75072548 2096000 Dead/Cancelled
    Sheehan, William
    1996-03-14
    NIACIN
    NIACIN
    75072506 not registered Dead/Abandoned
    Niacin
    1996-03-14

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