isosorbide mononitrate

Product NDC: 43063-313
Requested package NDC: 43063-313-30
11-digit product format: 430630313
Labeler code: 43063
Product ID: 43063-313_e6629504-b212-4cd1-e053-2a95a90a2826
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide mononitrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA075155
Marketing category: ANDA
Marketing start: 1998-10-30
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: 2023-12-31
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	43063-313	43063-313-30	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 · 12 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…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-313-30	EA - Each	43063-313	b1781312-b4a5-4917-b694-1b2752a50e03	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	4
ISOSORBIDE	ACTIVE MOIETY	WXR179L51S	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	4

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
43063-313-30	43063031330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-313-30)	2011-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Mononitrate Extended-Release Tablets Rx only	PD-Rx Pharmaceuticals, Inc.	2023-09-26	HUMAN PRESCRIPTION DRUG LABEL	21