Isosorbide Dinitrate

Product NDC
63629-9593
11-digit product format
636299593
Labeler code
63629
Product ID
63629-9593_d39aa53f-52e2-45c6-93de-150f47e14bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211290
Marketing category
ANDA
Marketing start
2021-12-21
Substance
ISOSORBIDE DINITRATE
Active strength
40 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 DINITRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIA7306519N
Rxcui197840

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
63629-9593-1Isosorbide Dinitrate100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9593-1EA - Each63629-959391f05d1b-04bc-4358-895d-c8aa61ecd35112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9593ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20241024_73a1e6c0-71d0-4ba1-bbca-c067479e487d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197840isosorbide dinitrate 40 MG Oral TabletPSN73a1e6c0-71d0-4ba1-bbca-c067479e487d102
197840isosorbide dinitrate 40 MG Oral TabletSCD73a1e6c0-71d0-4ba1-bbca-c067479e487d102
197840ISDN 40 MG Oral TabletSY73a1e6c0-71d0-4ba1-bbca-c067479e487d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9593-163629959301100 TABLET in 1 BOTTLE (63629-9593-1) 100 tablet2021-12-210000-00-00NoNoCurrent