Home NDC 64850-910 Isradipine
Product NDC 64850-910
11-digit product format 648500910
Labeler code 64850
Product ID 64850-910_194819ab-8bf2-4f80-b9bb-a1209af1ba21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isradipine
Dosage form CAPSULE
Route ORAL
Labeler Elite Laboratories, Inc.
Application ANDA077169
Marketing category ANDA
Marketing start 2022-12-28
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 2026-12-31
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 A077169-001 ISRADIPINE ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 A077169-002 ISRADIPINE ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24
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 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 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 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197848 Internal RxNorm lookup 197849 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 64850-910-01 Isradipine 100 in 1 BOTTLE CAPSULE 100 2 64850-910-05 Isradipine 500 in 1 BOTTLE CAPSULE 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64850-910 ISRADIPINE CAPSULE [ELITE LABORATORIES, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20221229_acf7c376-6cb6-4857-b455-0bf5da29346c.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64850-910-01 64850091001 100 CAPSULE in 1 BOTTLE (64850-910-01) 100 capsule 2022-12-28 0000-00-00 No No Current 64850-910-05 64850091005 500 CAPSULE in 1 BOTTLE (64850-910-05) 500 capsule 2022-12-28 0000-00-00 No No Current