Isradipine

Product NDC
42291-062
11-digit product format
422910062
Labeler code
42291
Product ID
42291-062_485b4749-5065-6c1c-e063-6294a90ade38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isradipine
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA077317
Marketing category
ANDA
Marketing start
2023-06-09
Substance
ISRADIPINE
Active strength
2.5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isradipine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISRADIPINE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYO1UK1S598
Rxcui197848

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ad7ea44-442f-aa22-0f74-8d99d37b3abfProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-062-01Isradipine100 in 1 BOTTLECAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-062ISRADIPINE CAPSULE [AVKARE]1Current NDC, 1 package rows20230610_fdb4c50e-6e6f-a43d-e053-6294a90aa24f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197848isradipine 2.5 MG Oral CapsulePSNfdb4c50e-6e6f-a43d-e053-6294a90aa24f2
197848isradipine 2.5 MG Oral CapsuleSCDfdb4c50e-6e6f-a43d-e053-6294a90aa24f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-062-0142291006201100 CAPSULE in 1 BOTTLE (42291-062-01) 100 capsule2023-06-09NoNoCurrent