FDA.reportPublic FDA data

Isosorbide dinitrate

Product NDC
70710-1149
11-digit product format
707101149
Labeler code
70710
Product ID
70710-1149_60a0c153-add8-44d9-a2f1-4c333d0eb42d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA213057
Marketing category
ANDA
Marketing start
2019-11-25
Substance
ISOSORBIDE DINITRATE
Active strength
10 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isosorbide dinitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE DINITRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIA7306519N
Rxcui197839, 197840, 206842, 314055, 381056

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
70710-1149-0Isosorbide dinitrate1000 in 1 BOTTLETABLET10004
70710-1149-1Isosorbide dinitrate100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1149-1EA - Each70710-1149f9b6e3a9-2889-49ba-a2c9-8ee7b3d2855812020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1149ISOSORBIDE DINITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 2 package rows20240809_16818b32-ee5e-4e07-b848-31e892c4b98a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
381056isosorbide dinitrate 10 MG Oral TabletPSN16818b32-ee5e-4e07-b848-31e892c4b98a4
206842isosorbide dinitrate 20 MG Oral TabletPSN16818b32-ee5e-4e07-b848-31e892c4b98a4
197839isosorbide dinitrate 30 MG Oral TabletPSN16818b32-ee5e-4e07-b848-31e892c4b98a4
197840isosorbide dinitrate 40 MG Oral TabletPSN16818b32-ee5e-4e07-b848-31e892c4b98a4
314055isosorbide dinitrate 5 MG Oral TabletPSN16818b32-ee5e-4e07-b848-31e892c4b98a4
381056isosorbide dinitrate 10 MG Oral TabletSCD16818b32-ee5e-4e07-b848-31e892c4b98a4
206842isosorbide dinitrate 20 MG Oral TabletSCD16818b32-ee5e-4e07-b848-31e892c4b98a4
197839isosorbide dinitrate 30 MG Oral TabletSCD16818b32-ee5e-4e07-b848-31e892c4b98a4
197840isosorbide dinitrate 40 MG Oral TabletSCD16818b32-ee5e-4e07-b848-31e892c4b98a4
314055isosorbide dinitrate 5 MG Oral TabletSCD16818b32-ee5e-4e07-b848-31e892c4b98a4
381056ISDN 10 MG Oral TabletSY16818b32-ee5e-4e07-b848-31e892c4b98a4
206842ISDN 20 MG Oral TabletSY16818b32-ee5e-4e07-b848-31e892c4b98a4
197839ISDN 30 MG Oral TabletSY16818b32-ee5e-4e07-b848-31e892c4b98a4
197840ISDN 40 MG Oral TabletSY16818b32-ee5e-4e07-b848-31e892c4b98a4
314055ISDN 5 MG Oral TabletSY16818b32-ee5e-4e07-b848-31e892c4b98a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1149-0707101149001000 TABLET in 1 BOTTLE (70710-1149-0) 1000 tablet2019-11-250000-00-00NoNoCurrent
70710-1149-170710114901100 TABLET in 1 BOTTLE (70710-1149-1) 100 tablet2019-11-250000-00-00NoNoCurrent