Isosorbide Mononitrate

Product NDC: 23155-519
11-digit product format: 231550519
Labeler code: 23155
Product ID: 23155-519_649023db-b51a-4696-ae92-28c926efc2d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Mononitrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA075522
Marketing category: ANDA
Marketing start: 2017-01-05
Marketing end: 0000-00-00
Substance: ISOSORBIDE MONONITRATE
Active strength: 30 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	23155-519		D	Discontinued by firm	2026-08-17
excluded package	package	23155-519	23155-519-01	D	Discontinued by firm	2026-08-17
excluded package	package	23155-519	23155-519-03	D	Discontinued by firm	2026-08-17
excluded package	package	23155-519	23155-519-05	D	Discontinued by firm	2026-08-17

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-519-01	EA - Each	23155-519	28c4e9ef-87fb-428f-b4b4-c4fccbc5e9af	1	2017-03-06
23155-519-05	EA - Each	23155-519	4cc54f30-327a-41af-9af2-9a4b7566af35	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	4
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	4
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-519	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	8	Legacy NDC	20211203_ef08d90f-ba26-4b68-8e3a-d0320e4b0f8e.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
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	00270f4b-53e4-482b-9f99-aee57ace7831	5
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	65935a15-a023-1941-e053-2991aa0a5eb4	5
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	dca5ffde-4b95-4f47-b368-c1ad04ec27b7	5
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	00270f4b-53e4-482b-9f99-aee57ace7831	5
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	65935a15-a023-1941-e053-2991aa0a5eb4	5
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	dca5ffde-4b95-4f47-b368-c1ad04ec27b7	5
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	00270f4b-53e4-482b-9f99-aee57ace7831	5
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	65935a15-a023-1941-e053-2991aa0a5eb4	5
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	dca5ffde-4b95-4f47-b368-c1ad04ec27b7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-519-01	23155051901	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-01)	2017-01-05	0000-00-00	No	No	Current
23155-519-03	23155051903	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-03)	2017-01-05	0000-00-00	No	No	Current
23155-519-05	23155051905	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-05)	2017-01-05	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	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Dexcel Ltd.	2025-11-19	HUMAN PRESCRIPTION DRUG LABEL	10
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	REMEDYREPACK INC.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	14
Isosorbide Mononitrate Extended-release Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-06-06	HUMAN PRESCRIPTION DRUG LABEL	5
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	Bryant Ranch Prepack	2023-05-26	HUMAN PRESCRIPTION DRUG LABEL	101
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	REMEDYREPACK INC.	2022-01-31	HUMAN PRESCRIPTION DRUG LABEL	3
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	5