Isosorbide Dinitrate

Product NDC: 50268-448
11-digit product format: 502680448
Labeler code: 50268
Product ID: 50268-448_4a7f77ca-73e0-4162-e063-6294a90a1418
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA086925
Marketing category: ANDA
Marketing start: 2017-06-06
Substance: ISOSORBIDE DINITRATE
Active strength: 10 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A086925-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	10MG	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
A086925-001	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	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086925-001	ISOSORBIDE DINITRATE	10MG	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	A086925-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086925-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086925-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086925-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086925-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086925-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086925-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086925-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086925-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086925-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086925-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086925-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086925-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086925-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086925-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086925-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086925-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086925-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086925-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086925-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086925-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086925-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086925-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086925-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086925-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086925-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086925-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086925-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086925-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086925-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086925-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086925-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086925-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086925-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086925-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086925-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086925-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086925-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086925-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086925-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Isosorbide Dinitrate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOSORBIDE DINITRATE	10 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
0e5842f2-74f6-1f02-01bc-07578bd3b393	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
50268-448-11	Isosorbide Dinitrate	1 in 1 BLISTER PACK	TABLET	1		8
50268-448-15	Isosorbide Dinitrate	50 in 1 BOX, UNIT-DOSE	TABLET	50		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-448-11	EA - Each	50268-448	d62f5818-0c6c-47a1-b9da-cb309ed5da97	1	2017-08-11
50268-448-15	EA - Each	50268-448	5427d79d-814f-49fa-b3ac-a54c3cba2407	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-448	ISOSORBIDE DINITRATE TABLET ISOSORBIDE DINITRATE TABLET [AVPAK]	6	Current NDC, Legacy NDC, 2 package rows	20240110_0e5842f2-74f6-1f02-01bc-07578bd3b393.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 · 3 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): 086925 application number: ANDA086925
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	AvPAK	0e5842f2-74f6-1f02-01bc-07578bd3b393	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086925 application number: ANDA086925 ndc (product): 50268-448
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	American Health Packaging	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086925 application number: ANDA086925

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	0e5842f2-74f6-1f02-01bc-07578bd3b393	8
206842	isosorbide dinitrate 20 MG Oral Tablet	PSN	0e5842f2-74f6-1f02-01bc-07578bd3b393	8
314055	isosorbide dinitrate 5 MG Oral Tablet	PSN	0e5842f2-74f6-1f02-01bc-07578bd3b393	8
381056	isosorbide dinitrate 10 MG Oral Tablet	SCD	0e5842f2-74f6-1f02-01bc-07578bd3b393	8
206842	isosorbide dinitrate 20 MG Oral Tablet	SCD	0e5842f2-74f6-1f02-01bc-07578bd3b393	8
314055	isosorbide dinitrate 5 MG Oral Tablet	SCD	0e5842f2-74f6-1f02-01bc-07578bd3b393	8
381056	ISDN 10 MG Oral Tablet	SY	0e5842f2-74f6-1f02-01bc-07578bd3b393	8
206842	ISDN 20 MG Oral Tablet	SY	0e5842f2-74f6-1f02-01bc-07578bd3b393	8
314055	ISDN 5 MG Oral Tablet	SY	0e5842f2-74f6-1f02-01bc-07578bd3b393	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-448-11	50268044811	1 in 1 BLISTER PACK						Historical
50268-448-15	50268044815	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-448-15) / 1 TABLET in 1 BLISTER PACK (50268-448-11)	50 blister pack	2017-06-06	0000-00-00	No	No	Current