NDC 68462-807

Isradipine

Isradipine

Isradipine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc.,usa. The primary component is Isradipine.

Product ID68462-807_02ffa6f4-81c6-45c5-a9fd-a4353ab974ec
NDC68462-807
Product TypeHuman Prescription Drug
Proprietary NameIsradipine
Generic NameIsradipine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2014-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA077169
Labeler NameGlenmark Pharmaceuticals Inc.,USA
Substance NameISRADIPINE
Active Ingredient Strength3 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68462-807-01

100 CAPSULE in 1 BOTTLE (68462-807-01)
Marketing Start Date2018-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-807-05 [68462080705]

Isradipine CAPSULE
Marketing CategoryANDA
Application NumberANDA077169
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-31

NDC 68462-807-01 [68462080701]

Isradipine CAPSULE
Marketing CategoryANDA
Application NumberANDA077169
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-31

Drug Details

Active Ingredients

IngredientStrength
ISRADIPINE2.5 mg/1

OpenFDA Data

SPL SET ID:f880f4cb-b41f-4277-9944-866d8de0717f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197849
  • 197848
  • UPC Code
  • 0368462807019
  • 0368462808016
  • 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

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