Isosorbide Dinitrate

Product NDC
0143-1767
11-digit product format
001431767
Labeler code
0143
Product ID
0143-1767_b7c4af42-2c43-4c96-8c33-3711f10cb904
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
West-ward Pharmaceutical Corp
Application
ANDA086055
Marketing category
ANDA
Marketing start
1978-12-01
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
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0143-1767IInactivated by FDA2026-09-09
excluded packagepackage0143-17670143-1767-01IInactivated by FDA2026-09-09
excluded packagepackage0143-17670143-1767-10IInactivated by FDA2026-09-09
excluded packagepackage0143-17670143-1767-25IInactivated by FDA2026-09-09

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 2 · 88 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 packagepackage0143-1767-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-1767-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-1767-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1767-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1767-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1767-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1767-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1767-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1767-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1767-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1767-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1767-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1767-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1767-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1767-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1767-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1767-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1767-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1767-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1767-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1767-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1767-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1767-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1767-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1767-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1767-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1767-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1767-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1767-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1767-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1767-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1767-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1767-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1767-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1767-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1767-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0143-1767-108af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0143-1767-258af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0143-1767-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0143-1767-10834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0143-1767-25834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0143-1767-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0143-1767-101332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0143-1767-251332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0143-1767-011332a3947898…d4bfe170f9cd…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A086055-001ISOSORBIDE DINITRATEISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02
A086055-002ISOSORBIDE DINITRATEISOSORBIDE DINITRATE2.5MGTABLET / SUBLINGUAL1987-10-29

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 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07A086055-002ISOSORBIDE DINITRATE2.5MGTABLET / SUBLINGUAL1987-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A086055-002ISOSORBIDE DINITRATE2.5MGTABLET / SUBLINGUAL1987-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086055-002ISOSORBIDE DINITRATE2.5MGTABLET / SUBLINGUAL1987-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A086055-002ISOSORBIDE DINITRATE2.5MGTABLET / SUBLINGUAL1987-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-023f01610625f2…
2019-09-15 20:21 UTC2019-09A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A086055-001ISOSORBIDE DINITRATE5MGTABLET / SUBLINGUAL1987-11-02053a50430f4f…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-1767-01Isosorbide Dinitrate100 in 1 BOTTLETABLET1006
0143-1767-10Isosorbide Dinitrate1000 in 1 BOTTLETABLET10006
0143-1767-25Isosorbide Dinitrate100 in 1 BOX, UNIT-DOSETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1767-01EA - Each0143-1767724f7e26-afee-499f-971f-ed8d4fcc90e312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE DINITRATEACTIVE INGREDIENTIA7306519NISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
ISOSORBIDE DINITRATEACTIVE MOIETYIA7306519NISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
AMMONIUM PHOSPHATE, DIBASICINACTIVE INGREDIENT10LGE70FSUISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-1767ISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICAL CORP]6Legacy NDC, 3 package rows20120626_44ede034-1fa1-4993-9aa5-49e04fada541.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197838isosorbide dinitrate 2.5 MG Sublingual TabletPSN44ede034-1fa1-4993-9aa5-49e04fada5416
197841isosorbide dinitrate 5 MG Sublingual TabletPSN44ede034-1fa1-4993-9aa5-49e04fada5416
197838isosorbide dinitrate 2.5 MG Sublingual TabletSCD44ede034-1fa1-4993-9aa5-49e04fada5416
197841isosorbide dinitrate 5 MG Sublingual TabletSCD44ede034-1fa1-4993-9aa5-49e04fada5416
197838ISDN 2.5 MG Sublingual TabletSY44ede034-1fa1-4993-9aa5-49e04fada5416
197841ISDN 5 MG Sublingual TabletSY44ede034-1fa1-4993-9aa5-49e04fada5416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0143-1767-0100143176701100 in 1 BOTTLEHistorical
0143-1767-10001431767101000 in 1 BOTTLEHistorical
0143-1767-2500143176725100 in 1 BOX, UNIT-DOSEHistorical