isosorbide mononitrate

Product NDC: 81665-103
11-digit product format: 816650103
Labeler code: 81665
Product ID: 81665-103_dba5d0c5-88bc-4091-b882-43dddc70923e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide mononitrate
Dosage form: TABLET
Route: ORAL
Labeler: OMNIVIUM PHARMACEUTICALS LLC.
Application: NDA020215
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-05-02
Substance: ISOSORBIDE MONONITRATE
Active strength: 20 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 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
N020215-001	MONOKET	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30
N020215-002	MONOKET	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	RLD	1993-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020215-001	AB
N020215-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`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	N020215-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020215-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020215-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020215-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020215-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020215-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020215-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020215-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020215-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020215-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020215-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020215-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020215-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020215-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020215-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020215-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020215-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020215-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020215-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020215-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020215-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020215-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020215-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020215-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020215-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020215-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020215-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020215-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020215-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020215-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020215-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020215-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020215-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020215-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020215-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020215-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020215-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020215-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020215-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020215-002	AB	1	`bb7c543d1eb4…`

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	20 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311192	Internal RxNorm lookup
311197	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
cdf01e14-778b-4b3f-8372-1c18f266fb98	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
81665-103-10	isosorbide mononitrate	100 in 1 BOTTLE	TABLET	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81665-103-10	EA - Each	81665-103	0af1ad6e-4a18-45b0-a857-5f7bd7b5cdd6	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81665-103	ISOSORBIDE MONONITRATE TABLET [OMNIVIUM PHARMACEUTICALS LLC.]	1	Current NDC, 1 package rows	20240504_cdf01e14-778b-4b3f-8372-1c18f266fb98.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	3e0e013f-6887-fa72-e063-6294a90a18ca	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Coupler LLC	3dffc84e-93e4-0005-e063-6294a90aa9ca	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215
isosorbide mononitrate	ISOSORBIDE MONONITRATE	OMNIVIUM PHARMACEUTICALS LLC.	cdf01e14-778b-4b3f-8372-1c18f266fb98	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215 ndc (product): 81665-103
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Lannett Company, Inc.	bf9e7e35-7707-42a0-88d6-6292fa52bbfa	2020-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Proficient Rx LP	f871dfa7-219f-4704-8e4d-215caeb7408d	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215

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
311192	isosorbide mononitrate 10 MG Oral Tablet	PSN	cdf01e14-778b-4b3f-8372-1c18f266fb98	2
311197	isosorbide mononitrate 20 MG Oral Tablet	PSN	cdf01e14-778b-4b3f-8372-1c18f266fb98	2
311192	isosorbide mononitrate 10 MG Oral Tablet	SCD	cdf01e14-778b-4b3f-8372-1c18f266fb98	2
311197	isosorbide mononitrate 20 MG Oral Tablet	SCD	cdf01e14-778b-4b3f-8372-1c18f266fb98	2
311197	isosorbide mononitrate 20 MG Oral Tablet	PSN	3e0e013f-6887-fa72-e063-6294a90a18ca	1
311197	isosorbide mononitrate 20 MG Oral Tablet	SCD	3e0e013f-6887-fa72-e063-6294a90a18ca	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81665-103-10	81665010310	100 TABLET in 1 BOTTLE (81665-103-10)	100 tablet	2024-05-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Mononitrate Tablets, USP	Coupler LLC	2025-09-05	HUMAN PRESCRIPTION DRUG LABEL	1
Isosorbide Mononitrate Tablets, USP	OMNIVIUM PHARMACEUTICALS LLC. \| Lannett Company, Inc.	2025-08-06	HUMAN PRESCRIPTION DRUG LABEL	2
Isosorbide Mononitrate Tablets, USP	Bryant Ranch Prepack	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	100