Isosorbide

Product NDC: 68001-375
11-digit product format: 680010375
Labeler code: 68001
Product ID: 68001-375_9498fa14-1614-4a8e-b872-41c11745b01e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA088088
Marketing category: ANDA
Marketing start: 2018-11-30
Substance: ISOSORBIDE DINITRATE
Active strength: 20 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A088088-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02
A088088-002	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29
A088088-003	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A088088-001	AB
A088088-002	AB
A088088-003	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 · 52 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	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088088-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088088-003	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088088-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088088-003	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-003	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088088-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088088-003	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	A088088-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088088-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088088-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088088-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088088-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088088-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088088-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088088-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088088-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088088-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088088-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088088-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088088-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088088-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088088-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088088-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088088-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088088-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088088-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088088-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088088-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088088-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088088-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088088-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088088-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088088-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088088-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088088-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088088-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088088-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088088-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088088-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088088-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088088-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088088-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088088-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088088-001	AB	1	`a72a2bbeb626…`

Additional Listing Data#

Finished product: Yes
Brand name base: Isosorbide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOSORBIDE DINITRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IA7306519N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
206842	Internal RxNorm lookup
314055	Internal RxNorm lookup
381056	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9498fa14-1614-4a8e-b872-41c11745b01e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e9ed2ee5-d109-4795-bffe-c3b047717749	Product name	2	20250107
1ee44c84-1ad7-16b4-788d-a549f91b0f44	Product name	4	20230316
0dcc68a5-df0d-b1a6-ba71-3da99d94ffe9	Product name	1	20140508
b0c258c1-3fb1-4785-4031-5c4417fb7ecd	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-375-00	Isosorbide	100 in 1 BOTTLE, PLASTIC	TABLET	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-375-00	EA - Each	68001-375	053b07fe-7f5d-4a63-bc5a-26faf18dc3f1	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-375	ISOSORBIDE (ISOSORBIDE DINITRATE) TABLET [BLUEPOINT LABORATORIES]	1	Current NDC, Legacy NDC, 1 package rows	20181130_9498fa14-1614-4a8e-b872-41c11745b01e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Cardinal Health 107, LLC	5f585259-59ed-4648-b562-164f3746c821	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Major Pharmaceuticals	6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Golden State Medical Supply, Inc.	7f860fbd-f130-4652-e053-2991aa0a402e	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Hikma Pharmaceuticals USA Inc.	f0b9b320-0bf8-4342-b654-135ccb6755c2	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088
Isosorbide	ISOSORBIDE DINITRATE	BluePoint Laboratories	9498fa14-1614-4a8e-b872-41c11745b01e	2018-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088 ndc (product): 68001-375

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
381056	isosorbide dinitrate 10 MG Oral Tablet	PSN	9498fa14-1614-4a8e-b872-41c11745b01e	1
206842	isosorbide dinitrate 20 MG Oral Tablet	PSN	9498fa14-1614-4a8e-b872-41c11745b01e	1
314055	isosorbide dinitrate 5 MG Oral Tablet	PSN	9498fa14-1614-4a8e-b872-41c11745b01e	1
381056	isosorbide dinitrate 10 MG Oral Tablet	SCD	9498fa14-1614-4a8e-b872-41c11745b01e	1
206842	isosorbide dinitrate 20 MG Oral Tablet	SCD	9498fa14-1614-4a8e-b872-41c11745b01e	1
314055	isosorbide dinitrate 5 MG Oral Tablet	SCD	9498fa14-1614-4a8e-b872-41c11745b01e	1
381056	ISDN 10 MG Oral Tablet	SY	9498fa14-1614-4a8e-b872-41c11745b01e	1
206842	ISDN 20 MG Oral Tablet	SY	9498fa14-1614-4a8e-b872-41c11745b01e	1
314055	ISDN 5 MG Oral Tablet	SY	9498fa14-1614-4a8e-b872-41c11745b01e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-375-00	68001037500	100 TABLET in 1 BOTTLE, PLASTIC (68001-375-00)	100 tablet	2018-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISOSORBIDE DINITRATE TABLETS, USP	BluePoint Laboratories \| Hikma Pharmaceutical LLC	2018-11-30	HUMAN PRESCRIPTION DRUG LABEL	1