Isradipine

Product NDC: 68462-808
Requested package NDC: 68462-808-05
11-digit product format: 684620808
Labeler code: 68462
Product ID: 68462-808_02ffa6f4-81c6-45c5-a9fd-a4353ab974ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isradipine
Dosage form: CAPSULE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc.,USA
Application: ANDA077169
Marketing category: ANDA
Marketing start: 2014-05-15
Marketing end: 0000-00-00
Substance: ISRADIPINE
Active strength: 5 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68462-808	68462-808-05	D	Discontinued by firm		2026-08-07

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.

Application-product, TE code table
Application-product	TE code
A077169-001	AB
A077169-002	AB

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077169-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077169-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077169-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077169-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077169-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077169-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077169-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077169-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077169-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077169-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077169-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077169-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077169-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077169-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077169-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077169-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077169-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077169-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077169-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077169-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077169-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077169-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077169-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077169-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077169-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077169-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077169-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077169-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077169-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077169-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077169-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077169-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077169-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077169-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077169-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077169-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077169-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077169-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077169-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077169-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-808-01	EA - Each	68462-808	7ac8d19a-6a44-4c48-be90-ddf3e1e4c3dc	1	2019-06-19

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isradipine	ISRADIPINE	Elite Laboratories, Inc.	acf7c376-6cb6-4857-b455-0bf5da29346c	2019-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077169 application number: ANDA077169

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YO1UK1S598	ISRADIPINE	75695-93-1	ISRADIPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-808-05	68462080805	500 CAPSULE in 1 BOTTLE (68462-808-05)	500 capsule	2018-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isradipine Capsules, USP 2.5 mg and 5 mg Rx Only	Glenmark Pharmaceuticals Inc.,USA \| Elite Laboratories, Inc.	2018-10-01	HUMAN PRESCRIPTION DRUG LABEL	2