FDA.reportPublic FDA data

Isosorbide Dinitrate

Product NDC
50268-448
11-digit product format
502680448
Labeler code
50268
Product ID
50268-448_4a7f77ca-73e0-4162-e063-6294a90a1418
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA086925
Marketing category
ANDA
Marketing start
2017-06-06
Substance
ISOSORBIDE DINITRATE
Active strength
10 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isosorbide Dinitrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE DINITRATE10 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
50268-448-11Isosorbide Dinitrate1 in 1 BLISTER PACKTABLET18
50268-448-15Isosorbide Dinitrate50 in 1 BOX, UNIT-DOSETABLET508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-448-11EA - Each50268-448d62f5818-0c6c-47a1-b9da-cb309ed5da9712017-08-11
50268-448-15EA - Each50268-4485427d79d-814f-49fa-b3ac-a54c3cba240712017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-448ISOSORBIDE DINITRATE TABLET ISOSORBIDE DINITRATE TABLET [AVPAK]6Current NDC, Legacy NDC, 2 package rows20240110_0e5842f2-74f6-1f02-01bc-07578bd3b393.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
381056isosorbide dinitrate 10 MG Oral TabletPSN0e5842f2-74f6-1f02-01bc-07578bd3b3938
206842isosorbide dinitrate 20 MG Oral TabletPSN0e5842f2-74f6-1f02-01bc-07578bd3b3938
314055isosorbide dinitrate 5 MG Oral TabletPSN0e5842f2-74f6-1f02-01bc-07578bd3b3938
381056isosorbide dinitrate 10 MG Oral TabletSCD0e5842f2-74f6-1f02-01bc-07578bd3b3938
206842isosorbide dinitrate 20 MG Oral TabletSCD0e5842f2-74f6-1f02-01bc-07578bd3b3938
314055isosorbide dinitrate 5 MG Oral TabletSCD0e5842f2-74f6-1f02-01bc-07578bd3b3938
381056ISDN 10 MG Oral TabletSY0e5842f2-74f6-1f02-01bc-07578bd3b3938
206842ISDN 20 MG Oral TabletSY0e5842f2-74f6-1f02-01bc-07578bd3b3938
314055ISDN 5 MG Oral TabletSY0e5842f2-74f6-1f02-01bc-07578bd3b3938

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-448-11502680448111 in 1 BLISTER PACKHistorical
50268-448-155026804481550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-448-15) / 1 TABLET in 1 BLISTER PACK (50268-448-11) 50 blister pack2017-06-060000-00-00NoNoCurrent