NDC 49349-000

AFEDITAB CR

Nifedipine

AFEDITAB CR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack. The primary component is Nifedipine.

Product ID49349-000_0d4423d4-8764-489e-aee7-f2af160e3b60
NDC49349-000
Product TypeHuman Prescription Drug
Proprietary NameAFEDITAB CR
Generic NameNifedipine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-05-13
Marketing CategoryNDA / NDA
Application NumberNDA123456
Labeler NameRemedyRepack
Substance NameNIFEDIPINE
Active Ingredient Strength60 mg/60mg
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49349-000-02

30 mg in 1 BLISTER PACK (49349-000-02)
Marketing Start Date2010-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49349-000-02 [49349000002]

AFEDITAB CR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA123456
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-13
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE60 mg/60mg

OpenFDA Data

SPL SET ID:0e1c628c-6ee0-49bf-b0a0-17e2acac1e8a
Manufacturer
UNII

Pharmacological Class

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

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

NDCBrand NameGeneric Name
68151-4223Afeditab CRAfeditab CR
43353-782Afeditab CRAfeditab CR
43353-792Afeditab CRAfeditab CR
49349-000AFEDITAB CRAFEDITAB CR
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 [AFEDITAB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFEDITAB
AFEDITAB
76455223 2843689 Live/Registered
ACTAVIS HOLDCO US, INC.
2002-09-30
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