NDC 71335-0489

Nifedipine

Nifedipine

Nifedipine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Nifedipine.

Product ID71335-0489_0a59429c-bf31-4629-b55f-4f366a8d6e18
NDC71335-0489
Product TypeHuman Prescription Drug
Proprietary NameNifedipine
Generic NameNifedipine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA203126
Labeler NameBryant Ranch Prepack
Substance NameNIFEDIPINE
Active Ingredient Strength60 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0489-1

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0489-1)
Marketing Start Date2015-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0489-2 [71335048902]

Nifedipine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203126
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-30

NDC 71335-0489-4 [71335048904]

Nifedipine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203126
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-30

NDC 71335-0489-3 [71335048903]

Nifedipine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203126
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-30

NDC 71335-0489-1 [71335048901]

Nifedipine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203126
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-30

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE60 mg/1

OpenFDA Data

SPL SET ID:b81fb1d7-4c84-4bc2-942c-d843cc4b949d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1812013
  • 1812011

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68071-3025NifedipineNifedipine
    68071-3287NifedipineNifedipine
    68071-3036NifedipineNifedipine
    68071-3315NifedipineNifedipine
    68071-3382NifedipineNifedipine
    68071-3347NifedipineNifedipine
    68071-4097NifedipineNifedipine
    68071-3281NIFEdipineNIFEdipine
    68071-4334NifedipineNifedipine
    68071-3364NifedipineNifedipine
    68071-4411NifedipineNifedipine
    68071-4281nifedipinenifedipine
    68071-4558NifedipineNifedipine
    68084-022NifedipineNifedipine
    68084-603NifedipineNifedipine
    68084-598NifedipineNifedipine
    68084-923NifedipineNifedipine
    68084-597NifedipineNifedipine
    68151-2870NifedipineNifedipine
    68382-685NifedipineNifedipine
    68382-690NIFEDIPINENIFEDIPINE
    68382-687NifedipineNifedipine
    68382-686NifedipineNifedipine
    68382-688NIFEDIPINENIFEDIPINE
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