NDC 43353-782

Afeditab CR

Nifedipine

Afeditab CR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Nifedipine.

Product ID43353-782_5ef126e4-1e7f-4526-8052-148d3ff10a56
NDC43353-782
Product TypeHuman Prescription Drug
Proprietary NameAfeditab CR
Generic NameNifedipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2002-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA075659
Labeler NameAphena Pharma Solutions - Tennessee, 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 43353-782-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-782-30)
Marketing Start Date2002-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-782-18 [43353078218]

Afeditab CR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075659
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-01
Inactivation Date2020-01-31

NDC 43353-782-30 [43353078230]

Afeditab CR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075659
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-01
Inactivation Date2020-01-31

NDC 43353-782-80 [43353078280]

Afeditab CR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075659
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-01
Inactivation Date2020-01-31

NDC 43353-782-60 [43353078260]

Afeditab CR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075659
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE60 mg/1

OpenFDA Data

SPL SET ID:323351d8-de18-4cd6-9497-c2d5e8666414
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198035
  • 198034
  • 672920
  • 672921

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Afeditab CR" or generic name "Nifedipine"

    NDCBrand NameGeneric Name
    68151-4223Afeditab CRAfeditab CR
    43353-782Afeditab CRAfeditab CR
    43353-792Afeditab CRAfeditab CR
    49349-000AFEDITAB CRAFEDITAB CR
    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

    Trademark Results [Afeditab]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AFEDITAB
    AFEDITAB
    76455223 2843689 Live/Registered
    ACTAVIS HOLDCO US, INC.
    2002-09-30
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