NDC 53808-0500

Nifediac CC

Nifedipine

Nifediac CC is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Nifedipine.

Product ID53808-0500_eaac3a82-2f22-47b4-b3a2-41aab8d9c4af
NDC53808-0500
Product TypeHuman Prescription Drug
Proprietary NameNifediac CC
Generic NameNifedipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA076070
Labeler NameState of Florida DOH Central Pharmacy
Substance NameNIFEDIPINE
Active Ingredient Strength90 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53808-0500-1

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (53808-0500-1)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0500-1 [53808050001]

Nifediac CC TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076070
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE90 mg/1

OpenFDA Data

SPL SET ID:fa952140-c9f6-472d-a04f-96c44fe9bca8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 880437
  • 198036
    • UPC Code
  • 0300931023018

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Nifediac CC" or generic name "Nifedipine"

    NDCBrand NameGeneric Name
    53808-0500Nifediac CCNifediac CC
    53808-0388Nifediac CCNifediac CC
    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 [Nifediac CC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NIFEDIAC CC
    NIFEDIAC CC
    78179655 3000589 Dead/Cancelled
    TEVA PHARMACEUTICALS CURACAO N.V.
    2002-10-29
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