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

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