Isosorbide Mononitrate

Product NDC: 68071-3081
Requested package NDC: 68071-3081-9
11-digit product format: 680713081
Labeler code: 68071
Product ID: 68071-3081_bb12cdd1-6173-b57d-e053-2a95a90ac21e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Mononitrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA075522
Marketing category: ANDA
Marketing start: 2010-06-07
Marketing end: 0000-00-00
Substance: ISOSORBIDE MONONITRATE
Active strength: 60 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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	68071-3081	68071-3081-9	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, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075522-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-04-17
A075522-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075522-001	AB
A075522-002	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 3 · 84 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	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A075522-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075522-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075522-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075522-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075522-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075522-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075522-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075522-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075522-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075522-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075522-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075522-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075522-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075522-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075522-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075522-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075522-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075522-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075522-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075522-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075522-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075522-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075522-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075522-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075522-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075522-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075522-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075522-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075522-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075522-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075522-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075522-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075522-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075522-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075522-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075522-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075522-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075522-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075522-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075522-002	AB	1	`bb7c543d1eb4…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-3081-3	2024-07-19	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-6	2024-07-19	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-9	2024-07-19	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-3	2023-01-30	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-6	2023-01-30	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-9	2023-01-30	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-3	2021-02-11	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-6	2021-02-11	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-9	2021-02-11	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-3	2021-01-29	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-6	2021-01-29	Isosorbide Mononitrate Extended-release Tablets, USP Rx only
68071-3081-9	2021-01-29	Isosorbide Mononitrate Extended-release Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3081-3	Isosorbide Mononitrate	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	4
68071-3081-6	Isosorbide Mononitrate	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	4
68071-3081-9	Isosorbide Mononitrate	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3081	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS, INC.]	4	Legacy NDC, 3 package rows	20240720_4ab91ea4-3ddb-5fd3-e054-00144ff88e88.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 Mononitrate	ISOSORBIDE MONONITRATE	Coupler LLC	46b3030d-f492-da9d-e063-6294a90a31b3	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Chartwell RX, LLC	b38f43c8-d02d-4aee-ab23-e898cbfadfbc	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Bryant Ranch Prepack	cd60ded0-01d9-4a51-a8ad-cdfeb27d88fb	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Edenbridge Pharmaceuticals LLC.	0e3c4461-2e04-481f-a9e5-29f21cc71ec5	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	NuCare Pharmaceuticals,Inc.	65935a15-a023-1941-e053-2991aa0a5eb4	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522

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
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	4ab91ea4-3ddb-5fd3-e054-00144ff88e88	4
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	4ab91ea4-3ddb-5fd3-e054-00144ff88e88	4
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	4ab91ea4-3ddb-5fd3-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3081-9	68071308109	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-9)	2017-03-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Mononitrate Extended-release Tablets, USP Rx only	NuCare Pharmaceuticals, Inc.	2024-07-19	HUMAN PRESCRIPTION DRUG LABEL	4