Isosorbide Mononitrate

Product NDC: 42799-960
11-digit product format: 427990960
Labeler code: 42799
Product ID: 42799-960_7443a5b6-6153-4227-870c-3c710f1f2174
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Mononitrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Edenbridge Pharmaceuticals LLC.
Application: ANDA210822
Marketing category: ANDA
Marketing start: 2018-11-15
Substance: ISOSORBIDE MONONITRATE
Active strength: 120 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42799-960		D	Discontinued by firm		2026-08-17
excluded package	package	42799-960	42799-960-01	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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42799-960-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42799-960-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A210822-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210822-001	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	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210822-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-08-29	`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	A210822-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210822-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210822-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210822-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210822-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210822-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210822-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210822-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210822-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210822-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210822-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210822-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210822-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210822-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210822-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210822-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210822-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210822-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210822-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210822-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210822-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210822-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210822-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210822-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210822-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210822-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210822-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210822-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210822-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210822-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210822-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210822-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210822-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210822-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210822-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210822-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210822-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210822-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210822-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210822-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Isosorbide Mononitrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOSORBIDE MONONITRATE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LX1OH63030	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311196	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
7443a5b6-6153-4227-870c-3c710f1f2174	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cc3f7505-fd5d-aab9-1128-173349f98a63	Product name	4	20230113
f23201a1-1f10-4748-0041-3c03fbb37cfb	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42799-960-01	Isosorbide Mononitrate	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42799-960-01	EA - Each	42799-960	190d6645-1752-482a-b053-ac827876b68c	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42799-960	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [EDENBRIDGE PHARMACEUTICALS LLC.]	1	Current NDC	20230629_0e3c4461-2e04-481f-a9e5-29f21cc71ec5.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 Mononitrate	ISOSORBIDE MONONITRATE	Chartwell RX, LLC	b38f43c8-d02d-4aee-ab23-e898cbfadfbc	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210822 application number: ANDA210822
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Edenbridge Pharmaceuticals LLC.	7443a5b6-6153-4227-870c-3c710f1f2174	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210822 application number: ANDA210822 ndc (product): 42799-960

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LX1OH63030	ISOSORBIDE MONONITRATE	16051-77-7	ISOSORBIDE MONONITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311196	isosorbide mononitrate 120 MG 24HR Extended Release Oral Tablet	PSN	7443a5b6-6153-4227-870c-3c710f1f2174	1
311196	24 HR isosorbide mononitrate 120 MG Extended Release Oral Tablet	SCD	7443a5b6-6153-4227-870c-3c710f1f2174	1
311196	isosorbide mononitrate 120 MG 24 HR Extended Release Oral Tablet	SY	7443a5b6-6153-4227-870c-3c710f1f2174	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42799-960-01	42799096001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-960-01)	2023-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	Edenbridge Pharmaceuticals LLC.	2025-06-06	Human Prescription Drug Label	1