NDC 49999-476

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 Lake Erie Medical Dba Quality Care Products Llc. The primary component is Nifedipine.

Product ID49999-476_a32ada5b-8360-4e8d-8d78-2aca82a313ac
NDC49999-476
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 NameLake Erie Medical DBA Quality Care Products LLC
Substance NameNIFEDIPINE
Active Ingredient Strength60 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49999-476-60

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (49999-476-60)
Marketing Start Date2007-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-476-30 [49999047630]

Nifedipine Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077899
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-22
Marketing End Date2019-10-11

NDC 49999-476-60 [49999047660]

Nifedipine Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077899
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-22
Marketing End Date2015-12-31

NDC 49999-476-90 [49999047690]

Nifedipine Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077899
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-22
Marketing End Date2015-12-31

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE60 mg/1

OpenFDA Data

SPL SET ID:8dc63e02-43c6-47ef-9c82-8edccedabcbc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198035

    • 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
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