Isosorbide

Product NDC
68001-375
11-digit product format
680010375
Labeler code
68001
Product ID
68001-375_9498fa14-1614-4a8e-b872-41c11745b01e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA088088
Marketing category
ANDA
Marketing start
2018-11-30
Substance
ISOSORBIDE DINITRATE
Active strength
20 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE DINITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIA7306519N
Rxcui206842, 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
68001-375-00Isosorbide100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-375-00EA - Each68001-375053b07fe-7f5d-4a63-bc5a-26faf18dc3f112019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-375ISOSORBIDE (ISOSORBIDE DINITRATE) TABLET [BLUEPOINT LABORATORIES]1Current NDC, Legacy NDC, 1 package rows20181130_9498fa14-1614-4a8e-b872-41c11745b01e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
381056isosorbide dinitrate 10 MG Oral TabletPSN9498fa14-1614-4a8e-b872-41c11745b01e1
206842isosorbide dinitrate 20 MG Oral TabletPSN9498fa14-1614-4a8e-b872-41c11745b01e1
314055isosorbide dinitrate 5 MG Oral TabletPSN9498fa14-1614-4a8e-b872-41c11745b01e1
381056isosorbide dinitrate 10 MG Oral TabletSCD9498fa14-1614-4a8e-b872-41c11745b01e1
206842isosorbide dinitrate 20 MG Oral TabletSCD9498fa14-1614-4a8e-b872-41c11745b01e1
314055isosorbide dinitrate 5 MG Oral TabletSCD9498fa14-1614-4a8e-b872-41c11745b01e1
381056ISDN 10 MG Oral TabletSY9498fa14-1614-4a8e-b872-41c11745b01e1
206842ISDN 20 MG Oral TabletSY9498fa14-1614-4a8e-b872-41c11745b01e1
314055ISDN 5 MG Oral TabletSY9498fa14-1614-4a8e-b872-41c11745b01e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-375-0068001037500100 TABLET in 1 BOTTLE, PLASTIC (68001-375-00) 100 tablet2018-11-300000-00-00NoNoCurrent