NDC 50268-454

Isradipine

Isradipine

Isradipine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Isradipine.

Product ID50268-454_81de9232-6827-75e2-e053-2991aa0a606a
NDC50268-454
Product TypeHuman Prescription Drug
Proprietary NameIsradipine
Generic NameIsradipine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2014-01-06
Marketing CategoryANDA / ANDA
Application NumberANDA077317
Labeler NameAvPAK
Substance NameISRADIPINE
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 50268-454-15

50 BLISTER PACK in 1 BOX (50268-454-15) > 1 CAPSULE in 1 BLISTER PACK (50268-454-11)
Marketing Start Date2014-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-454-11 [50268045411]

Isradipine CAPSULE
Marketing CategoryANDA
Application NumberANDA077317
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-03

NDC 50268-454-15 [50268045415]

Isradipine CAPSULE
Marketing CategoryANDA
Application NumberANDA077317
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-06

Drug Details

Active Ingredients

IngredientStrength
ISRADIPINE2.5 mg/1

OpenFDA Data

SPL SET ID:ac51d3e3-ed76-e033-e1d6-1ffbd14d94c2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197849
  • 197848
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Isradipine" or generic name "Isradipine"

    NDCBrand NameGeneric Name
    16252-539IsradipineIsradipine
    16252-540IsradipineIsradipine
    42806-263IsradipineIsradipine
    42806-264IsradipineIsradipine
    50268-454IsradipineIsradipine
    50268-455IsradipineIsradipine
    60429-385IsradipineIsradipine
    60429-386IsradipineIsradipine
    64850-910IsradipineIsradipine
    64850-911IsradipineIsradipine
    68151-1333IsradipineIsradipine
    68462-807IsradipineIsradipine
    68462-808IsradipineIsradipine

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