Isosorbide Dinitrate

Product NDC: 42291-350
11-digit product format: 422910350
Labeler code: 42291
Product ID: 42291-350_d57ade58-4dc8-0eaf-e053-2a95a90a7932
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA087946
Marketing category: ANDA
Marketing start: 2016-06-07
Marketing end: 0000-00-00
Substance: ISOSORBIDE DINITRATE
Active strength: 30 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-350		D	Discontinued by firm		2026-08-17
excluded package	package	42291-350	42291-350-01	D	Discontinued by firm		2026-08-17

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
A087946-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087946-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087946-001	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	RS	1988-01-12	`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	A087946-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087946-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087946-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087946-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087946-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087946-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087946-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087946-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087946-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087946-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087946-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087946-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087946-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087946-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087946-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087946-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087946-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087946-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087946-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087946-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087946-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087946-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087946-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087946-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087946-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087946-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087946-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087946-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087946-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087946-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087946-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087946-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087946-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087946-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087946-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087946-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087946-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087946-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087946-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087946-001	AB	1	`e64feba35796…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-350	ISOSORBIDE DINITRATE TABLET [AVKARE]	5	Legacy NDC	20240110_8289b32e-05f9-02b0-3bdd-12ad55e3852a.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.

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): 087946 application number: ANDA087946

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-350-01	42291035001	100 TABLET in 1 BOTTLE (42291-350-01)	100 tablet	2016-06-07	0000-00-00	No	No	Current