NDC 67544-185

Adalat CC

Nifedipine

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

Product ID67544-185_28f2a162-654f-48d1-b0d8-41e06d8eca95
NDC67544-185
Product TypeHuman Prescription Drug
Proprietary NameAdalat CC
Generic NameNifedipine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1993-04-21
Marketing CategoryNDA / NDA
Application NumberNDA020198
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameNIFEDIPINE
Active Ingredient Strength90 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67544-185-81

800 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-185-81)
Marketing Start Date1993-04-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-185-82 [67544018582]

Adalat CC TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020198
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1993-04-21
Inactivation Date2020-01-31

NDC 67544-185-81 [67544018581]

Adalat CC TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020198
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1993-04-21
Inactivation Date2020-01-31

NDC 67544-185-60 [67544018560]

Adalat CC TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020198
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1993-04-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE90 mg/1

OpenFDA Data

SPL SET ID:8d247bfb-8309-4cb8-847c-b4619a3d36d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 672918
  • 198036

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    52427-494Adalat CCAdalat CC
    52427-495Adalat CCAdalat CC
    52427-496Adalat CCAdalat CC
    67544-185Adalat CCAdalat 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.