isosorbide mononitrate

Product NDC: 62175-119
11-digit product format: 621750119
Labeler code: 62175
Product ID: 62175-119_6d91cd6b-f0bf-4e23-97b2-8c659e6f8475
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide mononitrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA075155
Marketing category: ANDA
Marketing start: 1998-10-30
Marketing end: 2024-03-31
Substance: ISOSORBIDE MONONITRATE
Active strength: 60 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62175-119		D	Discontinued by firm	2026-08-17
excluded package	package	62175-119	62175-119-37	D	Discontinued by firm	2026-08-17
excluded package	package	62175-119	62175-119-41	D	Discontinued by firm	2026-08-17
excluded package	package	62175-119	62175-119-43	D	Discontinued by firm	2026-08-17
excluded package	package	62175-119	62175-119-46	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 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62175-119-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62175-119-43	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62175-119-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62175-119-41	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62175-119-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62175-119-43	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62175-119-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62175-119-41	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62175-119-46	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62175-119-43	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62175-119-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62175-119-41	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62175-119-46	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62175-119-43	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62175-119-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62175-119-41	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62175-119-46	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62175-119-43	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62175-119-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62175-119-41	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62175-119-46	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62175-119-43	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62175-119-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62175-119-41	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62175-119-46	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62175-119-43	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62175-119-37	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62175-119-41	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62175-119-46	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62175-119-43	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62175-119-37	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62175-119-41	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62175-119-46	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62175-119-43	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62175-119-37	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62175-119-41	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62175-119-46	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62175-119-43	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62175-119-37	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62175-119-41	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62175-119-46	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62175-119-43	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62175-119-37	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62175-119-41	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62175-119-46	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62175-119-43	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62175-119-37	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62175-119-41	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A075155-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30
A075155-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13
A075155-003	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075155-001	AB
A075155-002	AB
A075155-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`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	A075155-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075155-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075155-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075155-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075155-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075155-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075155-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075155-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075155-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075155-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075155-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075155-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075155-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075155-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075155-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075155-001	AB	1	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
62175-119-37	EA - Each	62175-119	da08d760-dd6b-4b74-ac51-c17017447e1e	1	2012-07-24
62175-119-41	EA - Each	62175-119	2e796c96-909a-4985-9fe8-c7eecb187281	1	2013-02-13
62175-119-43	EA - Each	62175-119	1cd2e5f5-0a0d-4558-bad4-f54106e57991	1	2012-07-24
62175-119-46	EA - Each	62175-119	0948b694-eab7-4bf0-b21b-430033cae157	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	9
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	9
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	9
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	9
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	8
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	8
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	4
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) TABLET, EXTENDED RELEASE [AVPAK]	4
ISOSORBIDE	ACTIVE MOIETY	WXR179L51S	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	4
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) TABLET, EXTENDED RELEASE [AVPAK]	4
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) TABLET, EXTENDED RELEASE [AVPAK]	4
Hydrogenated Castor Oil	INACTIVE INGREDIENT	ZF94AP8MEY	ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) TABLET, EXTENDED RELEASE [AVPAK]	4
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) TABLET, EXTENDED RELEASE [AVPAK]	4
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) TABLET, EXTENDED RELEASE [AVPAK]	4
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) TABLET, EXTENDED RELEASE [AVPAK]	4
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) TABLET, EXTENDED RELEASE [AVPAK]	4
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) TABLET, EXTENDED RELEASE [AVPAK]	4
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
ISOSORBIDE	ACTIVE MOIETY	WXR179L51S	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ISOSORBIDE	ACTIVE MOIETY	WXR179L51S	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

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	b14942c1-6162-4582-bc2c-2ff07a344dbd	5
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	b14942c1-6162-4582-bc2c-2ff07a344dbd	5
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	b14942c1-6162-4582-bc2c-2ff07a344dbd	5
311196	isosorbide mononitrate 120 MG 24HR Extended Release Oral Tablet	PSN	07c1c818-44ad-44b0-aeec-2bc51193cd52	3
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	07c1c818-44ad-44b0-aeec-2bc51193cd52	3
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	a707727c-819f-43ea-89f3-2a2ae1cb9edf	3
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	07c1c818-44ad-44b0-aeec-2bc51193cd52	3
311196	24 HR isosorbide mononitrate 120 MG Extended Release Oral Tablet	SCD	07c1c818-44ad-44b0-aeec-2bc51193cd52	3
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	07c1c818-44ad-44b0-aeec-2bc51193cd52	3
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	07c1c818-44ad-44b0-aeec-2bc51193cd52	3
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	a707727c-819f-43ea-89f3-2a2ae1cb9edf	3
311196	isosorbide mononitrate 120 MG 24 HR Extended Release Oral Tablet	SY	07c1c818-44ad-44b0-aeec-2bc51193cd52	3
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	07c1c818-44ad-44b0-aeec-2bc51193cd52	3
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	07c1c818-44ad-44b0-aeec-2bc51193cd52	3
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	a707727c-819f-43ea-89f3-2a2ae1cb9edf	3
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	2fdef9a2-61b6-43cc-8780-11e9f8bcc6f2	2
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	2fdef9a2-61b6-43cc-8780-11e9f8bcc6f2	2
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	2fdef9a2-61b6-43cc-8780-11e9f8bcc6f2	2
311196	isosorbide mononitrate 120 MG 24HR Extended Release Oral Tablet	PSN	cc6293ae-1f81-4670-84b2-c00422c690ca	1
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	cc6293ae-1f81-4670-84b2-c00422c690ca	1
311196	24 HR isosorbide mononitrate 120 MG Extended Release Oral Tablet	SCD	cc6293ae-1f81-4670-84b2-c00422c690ca	1
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	cc6293ae-1f81-4670-84b2-c00422c690ca	1
311196	isosorbide mononitrate 120 MG 24 HR Extended Release Oral Tablet	SY	cc6293ae-1f81-4670-84b2-c00422c690ca	1
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	cc6293ae-1f81-4670-84b2-c00422c690ca	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62175-119-37	62175011937	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-119-37)	1998-10-30	2024-03-31	No	No	Current
62175-119-41	62175011941	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-119-41)	1998-10-30	2024-03-31	No	No	Current
62175-119-43	62175011943	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-119-43)	1998-10-30	2024-03-31	No	No	Current
62175-119-46	62175011946	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-119-46)	1998-10-30	2024-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	Bryant Ranch Prepack	2023-10-25	HUMAN PRESCRIPTION DRUG LABEL	1006
Isosorbide Mononitrate Extended-Release Tablets Rx only	PD-Rx Pharmaceuticals, Inc.	2023-09-26	HUMAN PRESCRIPTION DRUG LABEL	21
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	REMEDYREPACK INC.	2023-03-17	HUMAN PRESCRIPTION DRUG LABEL	2
Isosorbide Mononitrate Extended-Release Tablets, USP 8259101/0117 Rx only	American Health Packaging	2022-06-07	HUMAN PRESCRIPTION DRUG LABEL	14
Isosorbide Mononitrate Extended-Release Tablets Rx only	AvPAK	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	8
Isosorbide Mononitrate Extended-Release Tablets Rx only	Aphena Pharma Solutions - Tennessee, LLC	2019-12-23	HUMAN PRESCRIPTION DRUG LABEL	3
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only	Lannett Company, Inc. \| Apace Packaging LLC	2019-02-28	HUMAN PRESCRIPTION DRUG LABEL	19
Isosorbide Mononitrate Extended-Release Tablets Rx only	A-S Medication Solutions	2018-08-23	HUMAN PRESCRIPTION DRUG LABEL	5
Isosorbide Mononitrate Extended-Release Tablets Rx only	Carilion Materials Management	2015-12-29	HUMAN PRESCRIPTION DRUG LABEL	2
Isosorbide Mononitrate Extended-Release Tablets Rx only	Physicians Total Care, Inc.	2012-04-17	HUMAN PRESCRIPTION DRUG LABEL	3
Isosorbide Mononitrate Extended-Release Tablets Rx only	Rebel Distributors Corp	2011-06-30	HUMAN PRESCRIPTION DRUG LABEL	1