Isosorrbide Dinitrate

Product NDC
0143-1773
11-digit product format
001431773
Labeler code
0143
Product ID
0143-1773_1bf5a3aa-3342-429a-8bd2-1d16550ba5c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbdie Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
West-ward Pharmaceutical Corp
Application
ANDA040591
Marketing category
ANDA
Marketing start
2007-01-10
Marketing end
0000-00-00
Substance
ISOSORBIDE DINITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0143-1773DDiscontinued by firm2026-08-17
excluded packagepackage0143-17730143-1773-01DDiscontinued by firm2026-08-17
excluded packagepackage0143-17730143-1773-05DDiscontinued by firm2026-08-17
excluded packagepackage0143-17730143-1773-10DDiscontinued by firm2026-08-17
excluded packagepackage0143-17730143-1773-30DDiscontinued by firm2026-08-17

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-1773-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-1773-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-1773-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-1773-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1773-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1773-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1773-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1773-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1773-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1773-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1773-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1773-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1773-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1773-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1773-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1773-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1773-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1773-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1773-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1773-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1773-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1773-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1773-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1773-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1773-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1773-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1773-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1773-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1773-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1773-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1773-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1773-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1773-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1773-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1773-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1773-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1773-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1773-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1773-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1773-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1773-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1773-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1773-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1773-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1773-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1773-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1773-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1773-01557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040591-001ISOSORBIDE DINITRATEISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORALAB2007-01-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORALAB2007-01-103f01610625f2…
2019-09-15 20:21 UTC2019-09A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORALAB2007-01-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORALAB2007-01-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040591-001ISOSORBIDE DINITRATE30MGTABLET / ORAL2007-01-10e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040591-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A040591-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040591-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040591-001AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
1ee44c84-1ad7-16b4-788d-a549f91b0f44Product name420230316
0dcc68a5-df0d-b1a6-ba71-3da99d94ffe9Product name120140508
b0c258c1-3fb1-4785-4031-5c4417fb7ecdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-1773-01Isosorbide Dinitrate100 in 1 BOTTLE, PLASTICTABLET1001
0143-1773-05Isosorbide Dinitrate500 in 1 BOTTLE, PLASTICTABLET5001
0143-1773-10Isosorbide Dinitrate1000 in 1 BOTTLE, PLASTICTABLET10001
0143-1773-30Isosorbide Dinitrate30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1773-01EA - Each0143-177338b611b5-9a7b-4fe2-bceb-8714d6ff63a212013-02-13
0143-1773-10EA - Each0143-1773adb4489e-093a-4ad4-b15b-9a2bbccb5d5a12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-1773ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) TABLET [WEST-WARD PHARMACEUTICAL CORP.]1Legacy NDC, 4 package rows20080310_8bb91825-b63e-44aa-8edd-4326823f3009.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197839isosorbide dinitrate 30 MG Oral TabletPSN8bb91825-b63e-44aa-8edd-4326823f30091
197839isosorbide dinitrate 30 MG Oral TabletSCD8bb91825-b63e-44aa-8edd-4326823f30091
197839ISDN 30 MG Oral TabletSY8bb91825-b63e-44aa-8edd-4326823f30091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0143-1773-0100143177301100 in 1 BOTTLE, PLASTICHistorical
0143-1773-0500143177305500 in 1 BOTTLE, PLASTICHistorical
0143-1773-10001431773101000 in 1 BOTTLE, PLASTICHistorical
0143-1773-300014317733030 in 1 BOTTLE, PLASTICHistorical