NDC 68151-4068

Niaspan

Niacin

Niaspan is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Niacin.

Product ID68151-4068_97bea64c-c8e2-4c8c-9586-430b7b19015a
NDC68151-4068
Product TypeHuman Prescription Drug
Proprietary NameNiaspan
Generic NameNiacin
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-06-29
Marketing CategoryNDA / NDA
Application NumberNDA020381
Labeler NameCarilion Materials Management
Substance NameNIACIN
Active Ingredient Strength500 mg/1
Pharm ClassesNicotinic Acid [EPC],Nicotinic Acids [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68151-4068-9

1 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (68151-4068-9)
Marketing Start Date2010-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68151-4068-9 [68151406809]

Niaspan TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020381
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NIACIN500 mg/1

OpenFDA Data

SPL SET ID:0dd18020-c211-423d-b3d8-a926ae626e14
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098142
  • 1098141
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0074-3265NiaspanNiacin
    0074-3274NiaspanNiacin
    0074-3275NiaspanNiacin
    21695-852NiaspanNiacin
    21695-865NiaspanNiacin
    50090-1536NiaspanNiacin
    68151-4069NiaspanNiaspan
    68151-4068NiaspanNiaspan
    68258-6032NiaspanNiaspan
    68258-6037NiaspanNiaspan
    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
    0245-0067NiacorNiacin

    Trademark Results [Niaspan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NIASPAN
    NIASPAN
    78711536 3141685 Dead/Cancelled
    ABBOTT RESPIRATORY LLC
    2005-09-13
    NIASPAN
    NIASPAN
    78458856 3065193 Dead/Cancelled
    ABBOTT RESPIRATORY LLC
    2004-07-29
    NIASPAN
    NIASPAN
    76428724 not registered Dead/Abandoned
    Kos Pharmaceuticals, Inc.
    2002-06-27
    NIASPAN
    NIASPAN
    73838497 1611010 Live/Registered
    KOS PHARMACEUTICALS, INC.
    1989-11-13

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.