NDC 55648-412

FELODIPINE

Felodipine

FELODIPINE is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Felodipine.

Product ID55648-412_a0bf854d-54eb-42f1-891b-3facd48042f0
NDC55648-412
Product TypeHuman Prescription Drug
Proprietary NameFELODIPINE
Generic NameFelodipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-12-05
Marketing CategoryANDA / ANDA
Application NumberANDA091484
Labeler NameWOCKHARDT LIMITED
Substance NameFELODIPINE
Active Ingredient Strength5 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55648-412-01

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-412-01)
Marketing Start Date2010-12-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-412-04 [55648041204]

FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091484
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-05
Inactivation Date2020-01-31

NDC 55648-412-03 [55648041203]

FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091484
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-05
Inactivation Date2020-01-31

NDC 55648-412-01 [55648041201]

FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091484
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-05
Inactivation Date2020-01-31

NDC 55648-412-02 [55648041202]

FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091484
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-05
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FELODIPINE5 mg/1

OpenFDA Data

SPL SET ID:b4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402698
  • 402695
  • 402696
    • UPC Code
  • 0364679414040
  • 0364679412022
  • 0364679411025

    • Pharmacological Class

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

    NDC Crossover Matching brand name "FELODIPINE" or generic name "Felodipine"

    NDCBrand NameGeneric Name
    0378-5011FelodipineFelodipine
    0378-5012FelodipineFelodipine
    0378-5013FelodipineFelodipine
    0603-3581FelodipineFelodipine
    0603-3582FelodipineFelodipine
    0603-3583FelodipineFelodipine
    0615-6572FelodipineFelodipine
    0615-6573FelodipineFelodipine
    13668-132FelodipineFelodipine
    13668-133FelodipineFelodipine
    13668-134FelodipineFelodipine
    23155-048FelodipineFelodipine
    23155-049FelodipineFelodipine
    23155-050FelodipineFelodipine
    45865-445FelodipineFelodipine
    45865-446FelodipineFelodipine
    50090-1125FelodipineFelodipine
    50090-2421FelodipineFelodipine
    50090-4808FelodipineFelodipine Extended-release Tablets
    50090-5870FelodipineFelodipine
    51079-467FelodipineFelodipine
    51407-087FelodipineFelodipine
    51407-088FelodipineFelodipine
    51407-089FelodipineFelodipine
    68071-4466FelodipineFelodipine
    68151-3083FelodipineFelodipine
    68151-3084FelodipineFelodipine
    68462-235FelodipineFelodipine
    68462-233FelodipineFelodipine
    68462-234FelodipineFelodipine
    69117-0029FelodipineFelodipine
    69117-0030FelodipineFelodipine
    69117-0028FelodipineFelodipine
    53489-368FelodipineFelodipine
    53489-369FelodipineFelodipine
    53489-370FelodipineFelodipine
    55289-306FelodipineFelodipine
    55648-412FELODIPINEFELODIPINE
    55648-414FELODIPINEFELODIPINE
    55648-411FELODIPINEFELODIPINE
    57237-110FelodipineFelodipine
    57237-108FelodipineFelodipine
    57237-109FelodipineFelodipine
    59746-370FelodipineFelodipine
    59746-369FelodipineFelodipine
    59746-371FelodipineFelodipine
    63629-5418FelodipineFelodipine
    64679-411FELODIPINEFELODIPINE
    64679-414FELODIPINEFELODIPINE
    64679-412FELODIPINEFELODIPINE
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