Isosorbide Mononitrate

Product NDC: 11788-160
11-digit product format: 117880160
Labeler code: 11788
Product ID: 11788-160_15a9231a-e601-4428-8626-c1f8ca083fc7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Mononitrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: AiPing Pharmaceutical, Inc.
Application: ANDA214115
Marketing category: ANDA
Marketing start: 2026-10-30
Substance: ISOSORBIDE MONONITRATE
Active strength: 60 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214115-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29
A214115-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08
A214115-003	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214115-001	AB
A214115-002	AB
A214115-003	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 · 70 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
2026-10-15 13:18:30	2026-09	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214115-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214115-003	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214115-001	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-29	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A214115-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214115-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214115-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214115-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214115-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214115-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214115-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214115-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214115-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214115-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214115-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214115-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214115-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214115-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214115-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214115-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214115-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214115-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214115-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214115-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214115-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214115-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214115-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214115-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214115-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214115-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214115-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214115-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214115-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214115-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214115-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214115-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214115-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214115-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214115-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214115-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214115-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214115-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214115-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214115-001	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Isosorbide Mononitrate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOSORBIDE MONONITRATE	60 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
21bd9824-537d-4bcd-8093-1270df52c29c	Available on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Shandong New Time Pharmaceutical Co., Ltd.	cd953cfa-b6f5-4b82-afcc-52a57236b9d3	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214115 application number: ANDA214115

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
11788-160-01	11788016001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (11788-160-01)	2026-10-30	No	No	Current
11788-160-05	11788016005	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (11788-160-05)	2026-10-30	No	No	Current
11788-160-10	11788016010	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (11788-160-10)	2026-10-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	AiPing Pharmaceutical, Inc. \| Shandong New Time Pharmaceutical Co., Ltd. \| Shandong New Time Pharmaceutical Co., Ltd	2026-10-26	HUMAN PRESCRIPTION DRUG LABEL	1