Isosorbide Dinitrate

Product NDC: 68001-223
11-digit product format: 680010223
Labeler code: 68001
Product ID: 68001-223_99d54a93-eaf7-5571-e053-2a95a90a477b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA086221
Marketing category: ANDA
Marketing start: 2014-02-06
Marketing end: 2021-05-31
Substance: ISOSORBIDE DINITRATE
Active strength: 5 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	68001-223		D	Discontinued by firm	2026-08-07
excluded package	package	68001-223	68001-223-00	D	Discontinued by firm	2026-08-07
excluded package	package	68001-223	68001-223-08	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 · 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	68001-223-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-223-08	`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	68001-223-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68001-223-08	`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	68001-223-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68001-223-08	`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	68001-223-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68001-223-08	`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	68001-223-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68001-223-08	`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	68001-223-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68001-223-08	`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	68001-223-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68001-223-08	`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	68001-223-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68001-223-08	`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	68001-223-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68001-223-08	`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	68001-223-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68001-223-08	`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	68001-223-00	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68001-223-08	`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	68001-223-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68001-223-08	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A086221-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB		1988-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086221-001	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 · 41 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	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086221-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1988-01-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A086221-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086221-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086221-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086221-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086221-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086221-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086221-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086221-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086221-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086221-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086221-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086221-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086221-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086221-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086221-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086221-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086221-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086221-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086221-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086221-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086221-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086221-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086221-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086221-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086221-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086221-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086221-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086221-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086221-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086221-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086221-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086221-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086221-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086221-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086221-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086221-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086221-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086221-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086221-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086221-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-223-00	EA - Each	68001-223	9f78457b-c7cd-456f-9f8a-1f611f13ffbf	1	2014-04-03
68001-223-08	EA - Each	68001-223	b53e6b57-36cd-4e9e-bb19-74650e7d1139	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES]	3
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES]	3
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Sandoz Inc.	71fdd147-a987-40b6-9f07-82d56525ceb8	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086221 application number: ANDA086221

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
68001-223-00	68001022300	100 TABLET in 1 BOTTLE (68001-223-00)	100 tablet	2014-02-06	2021-05-31	No	No	Current
68001-223-08	68001022308	1000 TABLET in 1 BOTTLE (68001-223-08)	1000 tablet	2014-02-06	2021-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Dinitrate Tablets, USP (Oral)	BluePoint Laboratories \| Sandoz Inc \| Eon Labs, Inc.	2019-12-16	HUMAN PRESCRIPTION DRUG LABEL	9
Isosorbide Dinitrate Tablets, USP (Oral) Rx Only 8289421/0618F	American Health Packaging	2018-12-26	HUMAN PRESCRIPTION DRUG LABEL	3