Home NDC 42291-062 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077317-001 ISRADIPINE ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 A077317-002 ISRADIPINE ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isradipine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISRADIPINE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YO1UK1S598 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197848 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-062-01 Isradipine 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-062 ISRADIPINE CAPSULE [AVKARE] 1 Current NDC, 1 package rows 20230610_fdb4c50e-6e6f-a43d-e053-6294a90aa24f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42291-062-01 42291006201 100 CAPSULE in 1 BOTTLE (42291-062-01) 100 capsule 2023-06-09 No No Current