NDC 49884-678

Nifedipine Extended Release

Nifedipine

Nifedipine Extended Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Nifedipine.

Product ID49884-678_be0ad7fd-6e38-496c-969c-7f4633295f20
NDC49884-678
Product TypeHuman Prescription Drug
Proprietary NameNifedipine Extended Release
Generic NameNifedipine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2007-06-22
Marketing CategoryANDA / ANDA
Application NumberANDA077899
Labeler NamePar Pharmaceutical, Inc.
Substance NameNIFEDIPINE
Active Ingredient Strength60 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49884-678-05

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (49884-678-05)
Marketing Start Date2007-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-678-05 [49884067805]

Nifedipine Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077899
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-22
Marketing End Date2018-01-30
Inactivation Date2019-11-27
Reactivation Date2019-12-02

NDC 49884-678-01 [49884067801]

Nifedipine Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077899
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-22
Marketing End Date2018-01-31
Inactivation Date2019-11-27
Reactivation Date2019-12-02

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE60 mg/1

OpenFDA Data

SPL SET ID:4617417a-08df-4417-a944-dfc30de183db
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198035
  • 198034

    • Pharmacological Class

    • Calcium Channel Antagonists [MoA]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]

    Medicade Reported Pricing

    49884067805 NIFEDIPINE ER 60 MG TABLET

    Pricing Unit: EA | Drug Type:

    49884067801 NIFEDIPINE ER 60 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Nifedipine Extended Release" or generic name "Nifedipine"

    NDCBrand NameGeneric Name
    49884-679Nifedipine Extended ReleaseNifedipine Extended Release
    49884-678Nifedipine Extended ReleaseNifedipine Extended Release
    49884-677Nifedipine Extended ReleaseNifedipine Extended Release
    49999-476Nifedipine Extended ReleaseNifedipine Extended Release
    53808-0898Nifedipine Extended ReleaseNifedipine Extended Release
    0228-2497NifedipineNifedipine
    0228-2530NifedipineNifedipine
    0378-0353Nifedipinenifedipine
    0378-0360Nifedipinenifedipine
    0378-0390Nifedipinenifedipine
    0378-0480Nifedipinenifedipine
    0378-0481Nifedipinenifedipine
    0378-0494Nifedipinenifedipine
    0615-5541Nifedipinenifedipine
    0615-6563Nifedipinenifedipine
    0615-7571NifedipineNifedipine
    0904-6544NifedipineNifedipine
    0904-6545NifedipineNifedipine
    0904-7080Nifedipinenifedipine
    0904-7081Nifedipinenifedipine
    0904-7082Nifedipinenifedipine
    0904-7208NifedipineNifedipine
    0904-7229NifedipineNifedipine
    10370-677NifedipineNifedipine
    10370-678NifedipineNifedipine
    10370-679NifedipineNifedipine
    21695-807nifedipinenifedipine
    21695-908nifedipinenifedipine
    21695-909NifedipineNifedipine
    23155-194NifedipineNifedipine
    23155-195NifedipineNifedipine
    0069-2600Procardianifedipine
    0069-2650Procardianifedipine
    0069-2660Procardianifedipine
    0069-2670Procardianifedipine
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.