Isosorbide Mononitrate

Product NDC: 71610-337
Requested package NDC: 71610-337-60
11-digit product format: 716100337
Labeler code: 71610
Product ID: 71610-337_e6ce8fcb-476d-40f5-b38f-be1f7253353e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Mononitrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA210918
Marketing category: ANDA
Marketing start: 2018-11-05
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: 2020-12-31
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	71610-337	71610-337-60	I	Inactivated by FDA		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 · 15 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
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210918-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05
A210918-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05
A210918-003	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210918-001	AB
A210918-002	AB
A210918-003	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 4 · 126 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	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210918-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210918-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210918-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-11-05	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A210918-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210918-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210918-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210918-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210918-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210918-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210918-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210918-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210918-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210918-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210918-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210918-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210918-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210918-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210918-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210918-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210918-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210918-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210918-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210918-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210918-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210918-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210918-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210918-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210918-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210918-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210918-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210918-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210918-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210918-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210918-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210918-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210918-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210918-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210918-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210918-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210918-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210918-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210918-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210918-001	AB	1	`1e350fbaab3a…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-337-30	2023-01-30	C162847	48780-1	f386c64a-0d7d-0266-e053-dadaa90a7c1a	Isosorbide Mononitrate Extended-Release Tablets, USP
71610-337-60	2023-01-30	C162847	48780-1	f386c64a-0d7d-0266-e053-dadaa90a7c1a	Isosorbide Mononitrate Extended-Release Tablets, USP
71610-337-80	2023-01-30	C162847	48780-1	f386c64a-0d7d-0266-e053-dadaa90a7c1a	Isosorbide Mononitrate Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-337-30	Isosorbide Mononitrate	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30	1
71610-337-60	Isosorbide Mononitrate	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	1
71610-337-80	Isosorbide Mononitrate	180 in 1 BOTTLE	TABLET, EXTENDED RELEASE	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-337-30	EA - Each	71610-337	3d87bc1e-90a4-401e-b8b8-d6f1ae29e98f	1	2019-10-07
71610-337-60	EA - Each	71610-337	4d3e8c4b-f21d-429b-b7b4-c88f3aeee9d3	1	2019-10-07
71610-337-80	EA - Each	71610-337	8d8c5281-8751-4367-bde4-052dd1a453c7	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-337	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 3 package rows	20190831_9ea70e22-9687-40eb-9388-744768a2b33a.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Northwind Health Company, LLC	df5fd5e2-3a7b-5a5b-e053-2995a90a0dd3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Golden State Medical Supply, Inc.	86be0e85-5337-bee4-e053-2a91aa0a8158	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Aphena Pharma Solutions - Tennessee, LLC	17525ff2-9ec0-15a1-e063-6394a90ab762	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Bryant Ranch Prepack	441ddd35-6cb8-44d0-8009-1635390ede83	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Aphena Pharma Solutions - Tennessee, LLC	0af6c67f-919d-4515-8074-f6c3aaa835b5	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Aphena Pharma Solutions - Tennessee, LLC	18cf36bc-e73f-4274-b381-c2f2aa02f57d	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	A-S Medication Solutions	adcca9b8-0505-4bbc-81ab-05efc7407b6b	2024-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	A-S Medication Solutions	4da5a0ac-574d-48ea-80ba-55344bfefb91	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Ingenus Pharmaceuticals, LLC	c950760f-0e32-483f-96f2-eecaf057c0ec	2023-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Bryant Ranch Prepack	96420729-2bc7-4d03-9c51-f786ea678998	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210918 application number: ANDA210918

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	9ea70e22-9687-40eb-9388-744768a2b33a	1
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	9ea70e22-9687-40eb-9388-744768a2b33a	1
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	9ea70e22-9687-40eb-9388-744768a2b33a	1
311196	24 HR isosorbide mononitrate 120 MG Extended Release Oral Tablet	SCD	9ea70e22-9687-40eb-9388-744768a2b33a	1
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	9ea70e22-9687-40eb-9388-744768a2b33a	1
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	9ea70e22-9687-40eb-9388-744768a2b33a	1
311196	isosorbide mononitrate 120 MG 24 HR Extended Release Oral Tablet	SY	9ea70e22-9687-40eb-9388-744768a2b33a	1
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	9ea70e22-9687-40eb-9388-744768a2b33a	1
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	9ea70e22-9687-40eb-9388-744768a2b33a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-337-60	71610033760	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-337-60)	2019-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Mononitrate Extended-Release Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-08-20	HUMAN PRESCRIPTION DRUG LABEL	1