Isosorbide Dinitrate

Product NDC: 60429-440
11-digit product format: 604290440
Labeler code: 60429
Product ID: 60429-440_7aa8d87a-e3c6-2b75-e053-2991aa0a388f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA086923
Marketing category: ANDA
Marketing start: 2015-09-04
Marketing end: 0000-00-00
Substance: ISOSORBIDE DINITRATE
Active strength: 5 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60429-440		D	Discontinued by firm	2026-08-17
excluded package	package	60429-440	60429-440-01	D	Discontinued by firm	2026-08-17
excluded package	package	60429-440	60429-440-10	D	Discontinued by firm	2026-08-17

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60429-440-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60429-440-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60429-440-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60429-440-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60429-440-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60429-440-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60429-440-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60429-440-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60429-440-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60429-440-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60429-440-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60429-440-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60429-440-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60429-440-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60429-440-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60429-440-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60429-440-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60429-440-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60429-440-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60429-440-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60429-440-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60429-440-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60429-440-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60429-440-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A086923-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB		1987-03-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A086923-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086923-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-03-12	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A086923-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086923-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086923-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086923-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086923-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086923-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086923-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086923-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086923-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086923-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086923-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086923-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086923-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086923-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086923-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086923-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086923-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086923-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086923-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086923-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086923-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086923-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086923-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086923-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086923-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086923-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086923-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086923-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086923-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086923-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086923-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086923-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086923-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086923-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086923-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086923-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086923-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086923-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086923-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086923-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60429-440-01	EA - Each	60429-440	1d287ced-a0c7-410d-b4c2-2472fd02c9e8	1	2016-01-13
60429-440-10	EA - Each	60429-440	4415aa57-d9e9-411f-be13-747f41a5ab9e	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISOSORBIDE DINITRATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE DINITRATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Par Health USA, LLC	6df6a2fa-c56c-4eb6-a485-c16585420eb0	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086923 application number: ANDA086923
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	AvPAK	0e5842f2-74f6-1f02-01bc-07578bd3b393	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086923 application number: ANDA086923

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IA7306519N	ISOSORBIDE DINITRATE	87-33-2	ISOSORBIDE DINITRATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Dinitrate Tablets	Golden State Medical Supply, Inc.	2021-02-04	HUMAN PRESCRIPTION DRUG LABEL	6