ISOSORBIDE DINITRATE

Product NDC: 0615-8463
11-digit product format: 006158463
Labeler code: 0615
Product ID: 0615-8463_e52655b8-2c52-4534-9f86-bb70ebff3321
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA215723
Marketing category: ANDA
Marketing start: 2022-07-08
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215723-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08
A215723-002	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08
A215723-003	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08
A215723-004	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08
A215723-005	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A215723-001	AB
A215723-002	AB
A215723-003	AB
A215723-004	AB
A215723-005	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 4 · 140 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	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	A215723-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215723-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215723-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-005	AB	1	`2680178bc6a6…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197839	Internal RxNorm lookup
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
74a7f767-fa2f-4640-be24-34a8a9128217	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
0615-8463-39	ISOSORBIDE DINITRATE	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8463	ISOSORBIDE DINITRATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	1	Current NDC, 1 package rows	20230524_74a7f767-fa2f-4640-be24-34a8a9128217.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	REMEDYREPACK INC.	829ed058-333f-453c-9f0e-9202e03acf97	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Advagen Pharma Ltd	b166eb5b-bad8-4663-9c05-1c43539dab2c	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Proficient Rx LP	1cf9b6dd-9d4e-4ea1-95ae-e9e46a3d1b20	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Proficient Rx LP	33d14f59-3ae8-4414-b826-06274cf0f3d9	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	74a7f767-fa2f-4640-be24-34a8a9128217	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723 ndc (product): 0615-8463

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	74a7f767-fa2f-4640-be24-34a8a9128217	1
206842	isosorbide dinitrate 20 MG Oral Tablet	PSN	74a7f767-fa2f-4640-be24-34a8a9128217	1
197839	isosorbide dinitrate 30 MG Oral Tablet	PSN	74a7f767-fa2f-4640-be24-34a8a9128217	1
381056	isosorbide dinitrate 10 MG Oral Tablet	SCD	74a7f767-fa2f-4640-be24-34a8a9128217	1
206842	isosorbide dinitrate 20 MG Oral Tablet	SCD	74a7f767-fa2f-4640-be24-34a8a9128217	1
197839	isosorbide dinitrate 30 MG Oral Tablet	SCD	74a7f767-fa2f-4640-be24-34a8a9128217	1
381056	ISDN 10 MG Oral Tablet	SY	74a7f767-fa2f-4640-be24-34a8a9128217	1
206842	ISDN 20 MG Oral Tablet	SY	74a7f767-fa2f-4640-be24-34a8a9128217	1
197839	ISDN 30 MG Oral Tablet	SY	74a7f767-fa2f-4640-be24-34a8a9128217	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0615-8463-39	00615846339	30 TABLET in 1 BLISTER PACK (0615-8463-39)	30 tablet	2023-05-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Dinitrate Tablets	NCS HealthCare of KY, LLC dba Vangard Labs	2023-05-22	HUMAN PRESCRIPTION DRUG LABEL	1