Isosorbide Dinitrate

Product NDC: 68084-082
11-digit product format: 680840082
Labeler code: 68084
Product ID: 68084-082_4133d711-2ce0-0891-e063-6294a90aeaab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA086925
Marketing category: ANDA
Marketing start: 2013-10-21
Substance: ISOSORBIDE DINITRATE
Active strength: 10 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 · 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: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
206842	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
5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	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
68084-082-01	Isosorbide Dinitrate	100 in 1 BOX, UNIT-DOSE	TABLET	100		10
68084-082-11	Isosorbide Dinitrate	1 in 1 BLISTER PACK	TABLET	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-082-01	EA - Each	68084-082	63584b9c-11ab-40be-892b-6f5c9b188179	1	2013-11-04
68084-082-11	EA - Each	68084-082	2350f595-bb40-48c5-b4d1-4d1029340c9b	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-082	ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]	9	Current NDC, Legacy NDC, 2 package rows	20241215_5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1.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
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 ndc (product): 68084-082

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	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	10
206842	isosorbide dinitrate 20 MG Oral Tablet	PSN	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	10
381056	isosorbide dinitrate 10 MG Oral Tablet	SCD	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	10
206842	isosorbide dinitrate 20 MG Oral Tablet	SCD	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	10
381056	ISDN 10 MG Oral Tablet	SY	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	10
206842	ISDN 20 MG Oral Tablet	SY	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-082-01	68084008201	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-082-01) / 1 TABLET in 1 BLISTER PACK (68084-082-11)	100 blister pack	2013-10-21	0000-00-00	No	No	Current
68084-082-11	68084008211	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Dinitrate Tablets, USP 8208201/0925 Rx only	American Health Packaging	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	10