NDC 0378-0494

Nifedipine

Nifedipine

Nifedipine is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc. The primary component is Nifedipine.

Product ID0378-0494_9c21d509-bad1-42b3-8c49-5d6a1fe6c2f0
NDC0378-0494
Product TypeHuman Prescription Drug
Proprietary NameNifedipine
Generic NameNifedipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2000-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA090649
Labeler NameMylan Pharmaceuticals Inc
Substance NameNIFEDIPINE
Active Ingredient Strength90 mg/1
Pharm ClassesCalcium Channel
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-0494-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0494-01)
Marketing Start Date2000-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0494-01 [00378049401]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090649
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-03-14
Marketing End Date2019-11-30

NDC 0378-0494-30 [00378049430]

Nifedipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090649
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-03-14
Marketing End Date2014-07-16

Drug Details

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.