Isosorbide dinitrate

Product NDC: 16714-010
Requested package NDC: 16714-010-01
11-digit product format: 167140010
Labeler code: 16714
Product ID: 16714-010_be0de7ff-f8d9-472f-a35c-252a2cf16954
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: Northstar Rx LLC
Application: ANDA213057
Marketing category: ANDA
Marketing start: 2020-05-01
Substance: ISOSORBIDE DINITRATE
Active strength: 30 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 43.

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
A213057-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20
A213057-002	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20
A213057-003	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20
A213057-004	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20
A213057-005	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213057-001	AB
A213057-002	AB
A213057-003	AB
A213057-004	AB
A213057-005	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 5 · 200 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
2026-09-14 22:38:34	2026-08	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213057-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213057-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213057-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213057-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213057-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213057-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213057-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213057-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	30 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197839	Internal RxNorm lookup
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
246c749d-aa28-44ce-8d42-984660afff2a	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
16714-010-01	Isosorbide dinitrate	100 in 1 BOTTLE	TABLET	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-010-01	EA - Each	16714-010	f29fe894-c51e-4874-9fe3-26f8fdb67b5d	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-010	ISOSORBIDE DINITRATE TABLET [NORTHSTAR RX LLC]	3	Current NDC, Legacy NDC, 1 package rows	20240809_246c749d-aa28-44ce-8d42-984660afff2a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Northstar Rx LLC	246c749d-aa28-44ce-8d42-984660afff2a	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213057 application number: ANDA213057 ndc (package): 16714-010-01 ndc (product): 16714-010 ndc11 (package): 16714001001
Isosorbide dinitrate	ISOSORBIDE DINITRATE	BluePoint Laboratories	f1d52e9a-8de1-61db-e053-2a95a90aae50	2024-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213057 application number: ANDA213057
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Zydus Pharmaceuticals (USA) Inc.	16818b32-ee5e-4e07-b848-31e892c4b98a	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213057 application number: ANDA213057
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Zydus Lifesciences Limited	5b0db8af-bcf9-458f-b752-420130cba428	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213057 application number: ANDA213057

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	246c749d-aa28-44ce-8d42-984660afff2a	5
206842	isosorbide dinitrate 20 MG Oral Tablet	PSN	246c749d-aa28-44ce-8d42-984660afff2a	5
197839	isosorbide dinitrate 30 MG Oral Tablet	PSN	246c749d-aa28-44ce-8d42-984660afff2a	5
314055	isosorbide dinitrate 5 MG Oral Tablet	PSN	246c749d-aa28-44ce-8d42-984660afff2a	5
381056	isosorbide dinitrate 10 MG Oral Tablet	SCD	246c749d-aa28-44ce-8d42-984660afff2a	5
206842	isosorbide dinitrate 20 MG Oral Tablet	SCD	246c749d-aa28-44ce-8d42-984660afff2a	5
197839	isosorbide dinitrate 30 MG Oral Tablet	SCD	246c749d-aa28-44ce-8d42-984660afff2a	5
314055	isosorbide dinitrate 5 MG Oral Tablet	SCD	246c749d-aa28-44ce-8d42-984660afff2a	5
381056	ISDN 10 MG Oral Tablet	SY	246c749d-aa28-44ce-8d42-984660afff2a	5
206842	ISDN 20 MG Oral Tablet	SY	246c749d-aa28-44ce-8d42-984660afff2a	5
197839	ISDN 30 MG Oral Tablet	SY	246c749d-aa28-44ce-8d42-984660afff2a	5
314055	ISDN 5 MG Oral Tablet	SY	246c749d-aa28-44ce-8d42-984660afff2a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-010-01	16714001001	100 TABLET in 1 BOTTLE (16714-010-01)	100 tablet	2020-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Dinitrate Tablets, USP RX Only	Northstar Rx LLC \| Zydus Lifesciences Global FZE \| Zydus Lifesciences Limited	2025-08-21	HUMAN PRESCRIPTION DRUG LABEL	5