NDC 68071-3036

Nifedipine

Nifedipine

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

Product ID68071-3036_49dcda70-98bc-07a1-e054-00144ff8d46c
NDC68071-3036
Product TypeHuman Prescription Drug
Proprietary NameNifedipine
Generic NameNifedipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2005-11-21
Marketing CategoryANDA / ANDA
Application NumberANDA077127
Labeler NameNuCare Pharmaceuticals, Inc.
Substance NameNIFEDIPINE
Active Ingredient Strength30 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68071-3036-9

90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-3036-9)
Marketing Start Date2017-03-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-3036-5 [68071303605]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077127
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-03
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-06

NDC 68071-3036-3 [68071303603]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077127
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-03
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-06

NDC 68071-3036-9 [68071303609]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077127
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-03
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-06

NDC 68071-3036-6 [68071303606]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077127
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-03
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-06

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE30 mg/1

OpenFDA Data

SPL SET ID:49dcda70-98ba-07a1-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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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