NDC 68382-689

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 ID68382-689_26237eb5-1dd8-4a56-b5cc-de4ccd7c393d
NDC68382-689
Product TypeHuman Prescription Drug
Proprietary NameNIFEDIPINE
Generic NameNifedipine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-08-18
Marketing CategoryANDA / ANDA
Application NumberANDA210184
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameNIFEDIPINE
Active Ingredient Strength60 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-689-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-01)
Marketing Start Date2018-08-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-689-16 [68382068916]

NIFEDIPINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-18

NDC 68382-689-95 [68382068995]

NIFEDIPINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-18

NDC 68382-689-01 [68382068901]

NIFEDIPINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-18

NDC 68382-689-10 [68382068910]

NIFEDIPINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-18

NDC 68382-689-77 [68382068977]

NIFEDIPINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA210184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-18

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE60 mg/1

OpenFDA Data

SPL SET ID:1c857df2-9cce-40de-95c3-b1274ed1e1bc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198035
  • 198034
  • 198036
    • UPC Code
  • 0368382690777
  • 0368382688163
  • 0368382689016
  • 0368382689771
  • 0368382688774
  • 0368382690012

    • 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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