NDC 63629-1559

Nifedical XL

Nifedipine

Nifedical XL is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Nifedipine.

Product ID63629-1559_4d0c14a7-3af6-45fc-bcd3-5e62b5566e46
NDC63629-1559
Product TypeHuman Prescription Drug
Proprietary NameNifedical XL
Generic NameNifedipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2001-02-09
Marketing CategoryANDA / ANDA
Application NumberANDA075289
Labeler NameBryant Ranch Prepack
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 63629-1559-5

7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-1559-5)
Marketing Start Date2005-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-1559-3 [63629155903]

Nifedical XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075289
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-06-20
Inactivation Date2020-01-31

NDC 63629-1559-1 [63629155901]

Nifedical XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-06-20
Inactivation Date2020-01-31

NDC 63629-1559-2 [63629155902]

Nifedical XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-06-20
Inactivation Date2020-01-31

NDC 63629-1559-5 [63629155905]

Nifedical XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075289
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-06-20
Inactivation Date2020-01-31

NDC 63629-1559-4 [63629155904]

Nifedical XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075289
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-06-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE30 mg/1

OpenFDA Data

SPL SET ID:37fecdfe-bf70-46c3-8fa1-2029290cfd55
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 360394
  • 1812011

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Nifedical XL" or generic name "Nifedipine"

    NDCBrand NameGeneric Name
    53808-0851Nifedical XLNifedical XL
    55154-4837Nifedical XLNifedical XL
    63629-1559Nifedical XLNifedical XL
    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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