NDC 0904-6544

Nifedipine Extended Release

Nifedipine

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

Product ID0904-6544_ee37b27f-0477-4fe1-bd82-4bd4cafbbaf6
NDC0904-6544
Product TypeHuman Prescription Drug
Proprietary NameNifedipine Extended Release
Generic NameNifedipine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2007-06-22
Marketing CategoryANDA / ANDA
Application NumberANDA077899
Labeler NameMajor Pharmaceuticals
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 0904-6544-61

100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-6544-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2007-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6544-61 [00904654461]

Nifedipine Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-22
Marketing End Date2007-06-22

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE30 mg/1

OpenFDA Data

SPL SET ID:ee37b27f-0477-4fe1-bd82-4bd4cafbbaf6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198035
  • 198034
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    49884-679Nifedipine Extended ReleaseNifedipine Extended Release
    49884-678Nifedipine Extended ReleaseNifedipine Extended Release
    49884-677Nifedipine Extended ReleaseNifedipine Extended Release
    49999-476Nifedipine Extended ReleaseNifedipine Extended Release
    53808-0898Nifedipine Extended ReleaseNifedipine Extended Release
    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
    0069-2600Procardianifedipine
    0069-2650Procardianifedipine
    0069-2660Procardianifedipine
    0069-2670Procardianifedipine

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