Isosorbide

Product NDC: 0143-2230
11-digit product format: 001432230
Labeler code: 0143
Product ID: 0143-2230_3a032922-f0d8-45d9-9c76-5a1bcc4b9b6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide mononitrate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA076813
Marketing category: ANDA
Marketing start: 2006-03-30
Marketing end: 2020-12-31
Substance: ISOSORBIDE MONONITRATE
Active strength: 30 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0143-2230		D	Discontinued by firm	2026-08-17
excluded package	package	0143-2230	0143-2230-01	D	Discontinued by firm	2026-08-17
excluded package	package	0143-2230	0143-2230-05	D	Discontinued by firm	2026-08-17
excluded package	package	0143-2230	0143-2230-10	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 · 48 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	0143-2230-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-2230-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-2230-05	`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	0143-2230-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-2230-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-2230-05	`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	0143-2230-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-2230-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-2230-05	`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	0143-2230-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-2230-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-2230-05	`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	0143-2230-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-2230-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-2230-05	`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	0143-2230-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-2230-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-2230-05	`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	0143-2230-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-2230-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-2230-05	`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	0143-2230-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-2230-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-2230-05	`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	0143-2230-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-2230-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-2230-05	`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	0143-2230-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-2230-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-2230-05	`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	0143-2230-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-2230-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-2230-05	`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	0143-2230-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-2230-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-2230-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076813-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL			2005-01-07
A076813-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL			2006-03-30

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	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2005-01-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076813-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076813-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076813-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076813-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076813-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076813-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076813-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076813-002	AB	1	`ea99ee380514…`

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
0143-2230-01	EA - Each	0143-2230	a0b23a97-bef5-44b7-92d7-04749156417e	1	2012-07-24
0143-2230-10	EA - Each	0143-2230	be733539-aeef-43eb-9994-7289e1443354	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
AMMONIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	10LGE70FSU	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
AMMONIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	10LGE70FSU	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [WEST-WARD PHARMACEUTICAL CORP]	11
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
AMMONIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	10LGE70FSU	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2

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	f8b3465a-d884-4a24-9b4e-87aa2df6f7d2	4
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	f8b3465a-d884-4a24-9b4e-87aa2df6f7d2	4
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	f8b3465a-d884-4a24-9b4e-87aa2df6f7d2	4

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS, USP Rev. 05/16 Rx Only	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	3
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS, USP Rev. 05/16 Rx Only	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	3
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS, USP Rev. 05/16 Rx Only	Hikma Pharmaceuticals USA Inc.	2017-10-27	HUMAN PRESCRIPTION DRUG LABEL	21
Isosorbide Mononitrate ER Tablets	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
Isosorbide Mononitrate ER	NCS HealthCare of KY, Inc dba Vangard Labs	2012-12-20	HUMAN PRESCRIPTION DRUG LABEL	13