NDC 68382-687

Nifedipine

Nifedipine

Nifedipine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Nifedipine.

Product ID68382-687_6184864f-454a-422d-96ea-9bff6d1823d3
NDC68382-687
Product TypeHuman Prescription Drug
Proprietary NameNifedipine
Generic NameNifedipine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-02-02
Marketing CategoryANDA / ANDA
Application NumberANDA210012
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameNIFEDIPINE
Active Ingredient Strength90 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68382-687-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-01)
Marketing Start Date2018-02-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-687-95 [68382068795]

Nifedipine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210012
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-02

NDC 68382-687-77 [68382068777]

Nifedipine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210012
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-02
Marketing End Date2019-02-11

NDC 68382-687-01 [68382068701]

Nifedipine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210012
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-02

NDC 68382-687-10 [68382068710]

Nifedipine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210012
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-02

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE90 mg/1

OpenFDA Data

SPL SET ID:657221d5-9eb8-42f9-8cdc-39cefc386f51
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1812015
  • 1812013
  • 1812011
  • UPC Code
  • 0368382686015
  • 0368382685018
  • 0368382687012
  • Pharmacological Class

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