NDC 0615-5541

Nifedipine

Nifedipine

Nifedipine is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Nifedipine.

Product ID0615-5541_a90a7ddb-457e-4ab4-b63e-c9f3b186f26a
NDC0615-5541
Product TypeHuman Prescription Drug
Proprietary NameNifedipine
Generic NameNifedipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA090649
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameNIFEDIPINE
Active Ingredient Strength30 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-5541-39

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-5541-39)
Marketing Start Date2010-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-5541-30 [00615554130]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090649
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-30
Marketing End Date2013-02-25

NDC 0615-5541-39 [00615554139]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090649
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-30
Marketing End Date2019-11-30

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE30 mg/1

OpenFDA Data

SPL SET ID:a22e8171-7f26-49b2-b719-8641ba036fc2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1812015
  • 1812013
  • 1812011
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68071-3025NifedipineNifedipine
    68071-3287NifedipineNifedipine
    68071-3036NifedipineNifedipine
    68071-3315NifedipineNifedipine
    68071-3382NifedipineNifedipine
    68071-3347NifedipineNifedipine
    68071-4097NifedipineNifedipine
    68071-3281NIFEdipineNIFEdipine
    68071-4334NifedipineNifedipine
    68071-3364NifedipineNifedipine
    68071-4411NifedipineNifedipine
    68071-4281nifedipinenifedipine
    68071-4558NifedipineNifedipine
    68084-022NifedipineNifedipine
    68084-603NifedipineNifedipine
    68084-598NifedipineNifedipine
    68084-923NifedipineNifedipine
    68084-597NifedipineNifedipine
    68151-2870NifedipineNifedipine
    68382-685NifedipineNifedipine
    68382-690NIFEDIPINENIFEDIPINE
    68382-687NifedipineNifedipine
    68382-686NifedipineNifedipine
    68382-688NIFEDIPINENIFEDIPINE

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