Isordil

Product NDC: 0187-0152
11-digit product format: 001870152
Labeler code: 0187
Product ID: 0187-0152_584b3956-bfa2-4b08-80c3-ff7de4516c40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: Bausch Health US LLC
Application: NDA012093
Marketing category: NDA
Marketing start: 2013-04-01
Marketing end: 0000-00-00
Substance: ISOSORBIDE DINITRATE
Active strength: 5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0187-0152		D	Discontinued by firm		2026-08-17
excluded package	package	0187-0152	0187-0152-01	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012093-001	ISORDIL	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29
N012093-002	ISORDIL	ISOSORBIDE DINITRATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29
N012093-005	ISORDIL	ISOSORBIDE DINITRATE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29
N012093-006	ISORDIL	ISOSORBIDE DINITRATE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29
N012093-007	ISORDIL	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	RLD	1988-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N012093-001	AB
N012093-007	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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 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	N012093-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012093-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-007	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-007	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012093-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012093-007	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012093-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012093-007	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012093-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012093-007	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012093-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012093-007	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012093-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012093-007	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012093-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012093-007	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012093-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012093-007	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012093-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012093-007	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012093-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012093-007	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012093-007	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012093-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012093-007	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012093-001	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-0152-01	EA - Each	0187-0152	72e87601-07ba-46a4-90e3-7ae9827ee88a	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-0152	ISORDIL TITRADOSE (ISOSORBIDE DINITRATE) TABLET [BAUSCH HEALTH US LLC]	12	Legacy NDC	20210121_8ddd2577-311a-4967-bb67-ad72e2b76f83.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Oceanside Pharmaceuticals	723d9f78-9d77-4575-af27-1aa117e6b8d7	2020-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012093 application number: NDA012093

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IA7306519N	ISOSORBIDE DINITRATE	87-33-2	ISOSORBIDE DINITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-0152-01	00187015201	100 TABLET in 1 BOTTLE (0187-0152-01)	100 tablet	2013-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isordil® Titradose® (isosorbide dinitrate) Tablets	Bausch Health US LLC \| Bausch Health Companies, Inc.	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	13