FDA.reportPublic FDA data

Isosorbide Dinitrate

Product NDC
49884-556
11-digit product format
498840556
Labeler code
49884
Product ID
49884-556_d5589720-1ed8-42bd-a234-539a37ba22e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
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
49884-556-01Isosorbide Dinitrate100 in 1 BOTTLETABLET10013
49884-556-10Isosorbide Dinitrate1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-556-01EA - Each49884-556813dd18d-c735-4167-a1f1-2beef5c0c83312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-556ISOSORBIDE DINITRATE TABLET [ENDO USA, INC.]13Current NDC, Legacy NDC, 2 package rows20241212_3d6164d7-3083-41c5-a6a6-7e144fe29f7d.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
197840isosorbide dinitrate 40 MG Oral TabletPSN3d6164d7-3083-41c5-a6a6-7e144fe29f7d13
197840isosorbide dinitrate 40 MG Oral TabletSCD3d6164d7-3083-41c5-a6a6-7e144fe29f7d13
197840ISDN 40 MG Oral TabletSY3d6164d7-3083-41c5-a6a6-7e144fe29f7d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-556-0149884055601100 TABLET in 1 BOTTLE (49884-556-01) 100 tablet2021-12-210000-00-00NoNoCurrent
49884-556-10498840556101000 TABLET in 1 BOTTLE (49884-556-10) 1000 tablet2021-12-010000-00-00NoNoCurrent