Isosorbide Dinitrate

Product NDC: 63629-2573
11-digit product format: 636292573
Labeler code: 63629
Product ID: 63629-2573_74af15ae-e3eb-4f55-b298-2d4d42cd92bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA086066
Marketing category: ANDA
Marketing start: 1978-12-01
Marketing end: 0000-00-00
Substance: ISOSORBIDE DINITRATE
Active strength: 10 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-2573		D	Discontinued by firm	2026-08-11
excluded package	package	63629-2573	63629-2573-1	D	Discontinued by firm	2026-08-11
excluded package	package	63629-2573	63629-2573-2	D	Discontinued by firm	2026-08-11
excluded package	package	63629-2573	63629-2573-3	D	Discontinued by firm	2026-08-11

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 · 56 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2573-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2573-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-2573-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2573-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2573-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-2573-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2573-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2573-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-2573-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2573-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2573-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-2573-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2573-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2573-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-2573-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2573-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2573-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-2573-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2573-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2573-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-2573-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-2573-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-2573-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-2573-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-2573-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-2573-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-2573-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-2573-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-2573-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-2573-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-2573-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-2573-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-2573-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-2573-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-2573-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-2573-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-2573-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-2573-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-2573-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-2573-1	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-2573-2	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-2573-3	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086066-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086066-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086066-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086066-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086066-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086066-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086066-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086066-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086066-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086066-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086066-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086066-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086066-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086066-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086066-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086066-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086066-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086066-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086066-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086066-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086066-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086066-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086066-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086066-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086066-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086066-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086066-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086066-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086066-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086066-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086066-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086066-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086066-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086066-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086066-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086066-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086066-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086066-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-2573-1	2020-10-16	ISOSORBIDE DINITRATE TABLETS, USP
63629-2573-2	2020-10-16	ISOSORBIDE DINITRATE TABLETS, USP
63629-2573-3	2020-10-16	ISOSORBIDE DINITRATE TABLETS, USP
63629-2573-1	2019-11-27	ISOSORBIDE DINITRATE TABLETS, USP
63629-2573-2	2019-11-27	ISOSORBIDE DINITRATE TABLETS, USP
63629-2573-3	2019-11-27	ISOSORBIDE DINITRATE TABLETS, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2573-1	EA - Each	63629-2573	9741ef0a-ac7e-42e7-be31-bc194002da87	1	2013-03-03
63629-2573-2	EA - Each	63629-2573	59e856e2-2b3d-46e3-8ad5-babdc06d3479	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]	1000
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]	1000
AMMONIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	10LGE70FSU	ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]	1000
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]	1000
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]	1000

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	ISOSORBIDE DINITRATE	BluePoint Laboratories	9498fa14-1614-4a8e-b872-41c11745b01e	2018-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086066 application number: ANDA086066

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
63629-2573-1	63629257301	30 TABLET in 1 BOTTLE (63629-2573-1)	30 tablet	2005-01-12	0000-00-00	No	No	Current
63629-2573-2	63629257302	90 TABLET in 1 BOTTLE (63629-2573-2)	90 tablet	2005-01-12	0000-00-00	No	No	Current
63629-2573-3	63629257303	100 TABLET in 1 BOTTLE (63629-2573-3)	100 tablet	2005-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISOSORBIDE DINITRATE TABLETS, USP	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	1003