Isosorbide Mononitrate

Product NDC: 63187-700
Requested package NDC: 63187-700-30
11-digit product format: 631870700
Labeler code: 63187
Product ID: 63187-700_b2212d27-a0f7-48a6-ac0c-6e1ae378cb18
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isosorbide Mononitrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA090598
Marketing category: ANDA
Marketing start: 2010-08-11
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	63187-700	63187-700-30	D	Discontinued by firm		2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-700	63187-700-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-700	63187-700-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A090598-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11
A090598-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11
A090598-003	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090598-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090598-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090598-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-08-11	`8072bd15b7f6…`

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	A090598-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090598-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090598-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090598-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090598-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090598-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090598-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090598-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090598-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090598-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090598-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090598-003	AB	1	`ea99ee380514…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-700	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	3	Legacy NDC	20191121_c63f56ec-cd8d-4f84-8d57-cdc0f7acfa9d.zip

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	Marketing end	Sample	Exclude flag	Status
63187-700-30	63187070030	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-700-30)	2016-05-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS USP 30 mg, 60 mg, and 120 mg	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3