NDC 63126-321

FELODIPINE

Felodipine

FELODIPINE is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Yung Shin Pharmaceutical Ind. Co., Ltd.. The primary component is Felodipine.

Product ID63126-321_ed33130e-be8c-4d3d-9c18-42f3f72fc716
NDC63126-321
Product TypeHuman Prescription Drug
Proprietary NameFELODIPINE
Generic NameFelodipine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-08-30
Marketing CategoryANDA / ANDA
Application NumberANDA204800
Labeler NameYung Shin Pharmaceutical Ind. Co., Ltd.
Substance NameFELODIPINE
Active Ingredient Strength3 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63126-321-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63126-321-01)
Marketing Start Date2019-08-30
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
FELODIPINE2.5 mg/1

OpenFDA Data

SPL SET ID:5eec0e72-f076-4a96-8382-979f04cccce9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402698
  • 402695
  • 402696
  • 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

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