ISOSORBIDE MONONITRATE

Product NDC: 68382-651
Requested package NDC: 68382-651-01
11-digit product format: 683820651
Labeler code: 68382
Product ID: 68382-651_0f30ef5c-bdf6-4823-8483-8d40cfe4e460
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide mononitrate
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA075395
Marketing category: ANDA
Marketing start: 2013-12-19
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: 2022-12-31
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	68382-651	68382-651-01	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 · 16 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
A075395-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16
A075395-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16
A075395-003	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075395-001	AB
A075395-002	AB
A075395-003	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	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075395-002	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075395-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075395-001	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-03-16	`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	A075395-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075395-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075395-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075395-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075395-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075395-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075395-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075395-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075395-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075395-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075395-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075395-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075395-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075395-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075395-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075395-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075395-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075395-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075395-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075395-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075395-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075395-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075395-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075395-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075395-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075395-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075395-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075395-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075395-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075395-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075395-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075395-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075395-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075395-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075395-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075395-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075395-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075395-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075395-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075395-001	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
68382-651-01	2022-07-29	C162847	48780-1	e4f33bdf-9b5a-d8a0-e053-dadaa90a6e4e	Isosorbide Mononitrate Extended-Release Tablets 30 mg, 60 mg, and 120 mg
68382-651-05	2022-07-29	C162847	48780-1	e4f33bdf-9b5a-d8a0-e053-dadaa90a6e4e	Isosorbide Mononitrate Extended-Release Tablets 30 mg, 60 mg, and 120 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68382-651-01	ISOSORBIDE MONONITRATE	100 in 1 BOTTLE	TABLET	100		7
68382-651-05	ISOSORBIDE MONONITRATE	500 in 1 BOTTLE	TABLET	500		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-651-01	EA - Each	68382-651	41bbf74a-c872-4a55-86b2-7db822d7dbd4	1	2014-08-01
68382-651-05	EA - Each	68382-651	0d4398d8-4794-4b8f-ab09-a5c18fea4972	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE MONONITRATE	ACTIVE INGREDIENT	LX1OH63030	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
ISOSORBIDE MONONITRATE	ACTIVE MOIETY	LX1OH63030	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-651	ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ]	7	Legacy NDC, 2 package rows	20211218_897a0327-25d4-4769-bd6a-0e674264017f.zip

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	897a0327-25d4-4769-bd6a-0e674264017f	7
317110	isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet	PSN	897a0327-25d4-4769-bd6a-0e674264017f	7
353538	isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet	PSN	897a0327-25d4-4769-bd6a-0e674264017f	7
311196	24 HR isosorbide mononitrate 120 MG Extended Release Oral Tablet	SCD	897a0327-25d4-4769-bd6a-0e674264017f	7
317110	24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet	SCD	897a0327-25d4-4769-bd6a-0e674264017f	7
353538	24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet	SCD	897a0327-25d4-4769-bd6a-0e674264017f	7
311196	isosorbide mononitrate 120 MG 24 HR Extended Release Oral Tablet	SY	897a0327-25d4-4769-bd6a-0e674264017f	7
317110	isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet	SY	897a0327-25d4-4769-bd6a-0e674264017f	7
353538	isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet	SY	897a0327-25d4-4769-bd6a-0e674264017f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-651-01	68382065101	100 TABLET in 1 BOTTLE (68382-651-01)	100 tablet	2013-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isosorbide Mononitrate Extended-Release Tablets 30 mg, 60 mg, and 120 mg	NCS HealthCare of KY, LLC dba Vangard Labs	2022-08-29	HUMAN PRESCRIPTION DRUG LABEL	6
Isosorbide Mononitrate Extended-Release Tablets 30 mg, 60 mg, and 120 mg	Zydus Pharmaceuticals (USA) Inc. \| Nesher Pharmaceuticals (USA) LLC	2021-12-17	HUMAN PRESCRIPTION DRUG LABEL	7