Isosorbide Dinitrate

Product NDC: 49884-556
11-digit product format: 498840556
Labeler code: 49884
Product ID: 49884-556_d5589720-1ed8-42bd-a234-539a37ba22e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA211290
Marketing category: ANDA
Marketing start: 2021-12-21
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49884-556	49884-556-10	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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
A211290-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB		2021-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211290-001	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.

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	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211290-001	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2021-11-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211290-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211290-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211290-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211290-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211290-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211290-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211290-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211290-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211290-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211290-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211290-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211290-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211290-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211290-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211290-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211290-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211290-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211290-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211290-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211290-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211290-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211290-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211290-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211290-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211290-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211290-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211290-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211290-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211290-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211290-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211290-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211290-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211290-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211290-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211290-001	CGT	2022-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211290-001	CGT	2022-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211290-001	CGT	2022-06-20	`4b0b4de00fa7…`
2023-01-26 05:58 UTC	2023-01	A211290-001	CGT	2022-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211290-001	CGT	2022-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211290-001	CGT	2022-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211290-001	CGT	2022-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211290-001	CGT	2022-06-20	`cb3db0bc1861…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197840	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
3d6164d7-3083-41c5-a6a6-7e144fe29f7d	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
49884-556-01	Isosorbide Dinitrate	100 in 1 BOTTLE	TABLET	100		13
49884-556-10	Isosorbide Dinitrate	1000 in 1 BOTTLE	TABLET	1000		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-556-01	EA - Each	49884-556	813dd18d-c735-4167-a1f1-2beef5c0c833	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-556	ISOSORBIDE DINITRATE TABLET [ENDO USA, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20241212_3d6164d7-3083-41c5-a6a6-7e144fe29f7d.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 · 2 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	3d6164d7-3083-41c5-a6a6-7e144fe29f7d	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211290 application number: ANDA211290 ndc (product): 49884-556
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Bryant Ranch Prepack	73a1e6c0-71d0-4ba1-bbca-c067479e487d	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211290 application number: ANDA211290

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	73a1e6c0-71d0-4ba1-bbca-c067479e487d	102
197840	isosorbide dinitrate 40 MG Oral Tablet	SCD	73a1e6c0-71d0-4ba1-bbca-c067479e487d	102
197840	ISDN 40 MG Oral Tablet	SY	73a1e6c0-71d0-4ba1-bbca-c067479e487d	102
197840	isosorbide dinitrate 40 MG Oral Tablet	PSN	3d6164d7-3083-41c5-a6a6-7e144fe29f7d	13
197840	isosorbide dinitrate 40 MG Oral Tablet	SCD	3d6164d7-3083-41c5-a6a6-7e144fe29f7d	13
197840	ISDN 40 MG Oral Tablet	SY	3d6164d7-3083-41c5-a6a6-7e144fe29f7d	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-556-01	49884055601	100 TABLET in 1 BOTTLE (49884-556-01)	100 tablet	2021-12-21	0000-00-00	No	No	Current
49884-556-10	49884055610	1000 TABLET in 1 BOTTLE (49884-556-10)	1000 tablet	2021-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Dinitrate Tablets, USP Rx only	Par Health USA, LLC	2026-07-22	HUMAN PRESCRIPTION DRUG LABEL	14
Isosorbide Dinitrate Tablets, USP Rx only	Bryant Ranch Prepack	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	102