NDC 0378-0353

Nifedipine

Nifedipine

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

Product ID0378-0353_d5517e8c-6f72-4ee3-967c-e60b00266b9f
NDC0378-0353
Product TypeHuman Prescription Drug
Proprietary NameNifedipine
Generic NameNifedipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA201071
Labeler NameMylan 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 Through2020-12-31

Packaging

NDC 0378-0353-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0353-01)
Marketing Start Date2010-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0353-10 [00378035310]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201071
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-20

NDC 0378-0353-01 [00378035301]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201071
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-20

NDC 0378-0353-93 [00378035393]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201071
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-20
Marketing End Date2014-01-27

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE30 mg/1

OpenFDA Data

SPL SET ID:49040b3a-0802-4a7d-b0c9-c7f47c1bbe10
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198035
  • 198034
  • 198036
  • UPC Code
  • 0303780390775
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.