NDC 0378-5012

Felodipine

Felodipine

Felodipine 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 Felodipine.

Product ID0378-5012_2727fa5d-7ba0-4fd4-a1f3-cd6a7108e5bc
NDC0378-5012
Product TypeHuman Prescription Drug
Proprietary NameFelodipine
Generic NameFelodipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-04-18
Marketing End Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA078855
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFELODIPINE
Active Ingredient Strength5 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN

Packaging

NDC 0378-5012-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5012-01)
Marketing Start Date2008-04-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5012-01 [00378501201]

Felodipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078855
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-04-18
Marketing End Date2019-10-31

NDC 0378-5012-05 [00378501205]

Felodipine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078855
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-04-18
Marketing End Date2018-08-31

Drug Details

Active Ingredients

IngredientStrength
FELODIPINE5 mg/1

OpenFDA Data

SPL SET ID:f94ae052-5d59-4750-aab7-1fdb989503aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402698
  • 402695
  • 402696
    • UPC Code
  • 0303785011019
  • 0303785012016
  • 0303785013013

    • 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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