Isosorbide Dinitrate

Product NDC: 68682-192
11-digit product format: 686820192
Labeler code: 68682
Product ID: 68682-192_723d9f78-9d77-4575-af27-1aa117e6b8d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: NDA012093
Marketing category: NDA
Marketing start: 2020-03-02
Substance: ISOSORBIDE DINITRATE
Active strength: 40 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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012093-001	ISORDIL	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29
N012093-002	ISORDIL	ISOSORBIDE DINITRATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29
N012093-005	ISORDIL	ISOSORBIDE DINITRATE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29
N012093-006	ISORDIL	ISOSORBIDE DINITRATE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29
N012093-007	ISORDIL	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	RLD	1988-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N012093-001	AB
N012093-007	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 79 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	N012093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-007	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-007	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012093-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012093-007	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012093-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012093-007	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012093-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012093-007	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012093-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012093-007	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012093-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012093-007	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012093-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012093-007	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012093-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012093-007	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012093-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012093-007	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012093-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012093-007	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012093-007	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012093-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012093-007	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012093-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012093-007	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012093-001	AB	1	`87673890dc5c…`

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	40 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
197840	Internal RxNorm lookup
314055	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
723d9f78-9d77-4575-af27-1aa117e6b8d7	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
68682-192-01	Isosorbide Dinitrate	100 in 1 BOTTLE	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
68682-192-01	EA - Each	68682-192	a0cf9823-0976-48ee-978f-8586826cdf92	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-192	ISOSORBIDE DINITRATE TABLET [OCEANSIDE PHARMACEUTICALS]	1	Current NDC, Legacy NDC, 1 package rows	20200617_723d9f78-9d77-4575-af27-1aa117e6b8d7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Oceanside Pharmaceuticals	723d9f78-9d77-4575-af27-1aa117e6b8d7	2020-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012093 application number: NDA012093 ndc (product): 68682-192

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
197840	isosorbide dinitrate 40 MG Oral Tablet	PSN	723d9f78-9d77-4575-af27-1aa117e6b8d7	1
314055	isosorbide dinitrate 5 MG Oral Tablet	PSN	723d9f78-9d77-4575-af27-1aa117e6b8d7	1
197840	isosorbide dinitrate 40 MG Oral Tablet	SCD	723d9f78-9d77-4575-af27-1aa117e6b8d7	1
314055	isosorbide dinitrate 5 MG Oral Tablet	SCD	723d9f78-9d77-4575-af27-1aa117e6b8d7	1
197840	ISDN 40 MG Oral Tablet	SY	723d9f78-9d77-4575-af27-1aa117e6b8d7	1
314055	ISDN 5 MG Oral Tablet	SY	723d9f78-9d77-4575-af27-1aa117e6b8d7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-192-01	68682019201	100 TABLET in 1 BOTTLE (68682-192-01)	100 tablet	2020-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Dinitrate Tablets	Oceanside Pharmaceuticals \| Bausch Health Companies Inc.	2020-03-02	HUMAN PRESCRIPTION DRUG LABEL	1