Home NDC 60429-385-01 Isradipine
Product NDC 60429-385
Requested package NDC 60429-385-01
11-digit product format 604290385
Labeler code 60429
Product ID 60429-385_92eb4310-c140-17dc-e053-2995a90a79db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isradipine
Dosage form CAPSULE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA077169
Marketing category ANDA
Marketing start 2006-04-24
Marketing end 0000-00-00
Substance ISRADIPINE
Active strength 3 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISRADIPINE ACTIVE INGREDIENT YO1UK1S598 ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 ISRADIPINE ACTIVE MOIETY YO1UK1S598 ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ISRADIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60429-385-01 60429038501 100 CAPSULE in 1 BOTTLE (60429-385-01) 100 capsule 2015-07-15 0000-00-00 No No Current