FDA.reportPublic FDA data

Isosorbide Dinitrate

Product NDC
49884-022
11-digit product format
498840022
Labeler code
49884
Product ID
49884-022_bb122d4c-8b22-44dd-9c60-772123f18a4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA087537
Marketing category
ANDA
Marketing start
1981-12-15
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 Dinitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE DINITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIA7306519N
Rxcui197839, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-022-012022-08-19C16284748780-1e4f33bdf-ad7f-d8a0-e053-dadaa90a6e4eISOSORBIDE DINITRATE TABLETS, USP Rx only
49884-022-102022-08-19C16284748780-1e4f33bdf-ad7f-d8a0-e053-dadaa90a6e4eISOSORBIDE DINITRATE TABLETS, USP Rx only
49884-022-012022-07-29C16284748780-1e4f33bdf-ad7f-d8a0-e053-dadaa90a6e4eISOSORBIDE DINITRATE TABLETS, USP Rx only
49884-022-102022-07-29C16284748780-1e4f33bdf-ad7f-d8a0-e053-dadaa90a6e4eISOSORBIDE DINITRATE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-022-01Isosorbide Dinitrate100 in 1 BOTTLETABLET10017
49884-022-10Isosorbide Dinitrate1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-022-01EA - Each49884-022918aa3bb-861c-49b4-8764-4b5e0c72dcb712013-04-01
49884-022-10EA - Each49884-0222ef55776-437a-4a41-9d67-6b9328ddd76f12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE DINITRATEACTIVE INGREDIENTIA7306519NISOSORBIDE DINITRATE TABLET [PAR PHARMACEUTICAL INC.]6
ISOSORBIDE DINITRATEACTIVE MOIETYIA7306519NISOSORBIDE DINITRATE TABLET [PAR PHARMACEUTICAL INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISOSORBIDE DINITRATE TABLET [PAR PHARMACEUTICAL INC.]6
ISOSORBIDE DINITRATEACTIVE INGREDIENTIA7306519NISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]1
ISOSORBIDE DINITRATEACTIVE MOIETYIA7306519NISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-022ISOSORBIDE DINITRATE TABLET [ENDO USA, INC.]17Current NDC, Legacy NDC, 2 package rows20240926_6df6a2fa-c56c-4eb6-a485-c16585420eb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
381056isosorbide dinitrate 10 MG Oral TabletPSN6df6a2fa-c56c-4eb6-a485-c16585420eb017
206842isosorbide dinitrate 20 MG Oral TabletPSN6df6a2fa-c56c-4eb6-a485-c16585420eb017
197839isosorbide dinitrate 30 MG Oral TabletPSN6df6a2fa-c56c-4eb6-a485-c16585420eb017
314055isosorbide dinitrate 5 MG Oral TabletPSN6df6a2fa-c56c-4eb6-a485-c16585420eb017
381056isosorbide dinitrate 10 MG Oral TabletSCD6df6a2fa-c56c-4eb6-a485-c16585420eb017
206842isosorbide dinitrate 20 MG Oral TabletSCD6df6a2fa-c56c-4eb6-a485-c16585420eb017
197839isosorbide dinitrate 30 MG Oral TabletSCD6df6a2fa-c56c-4eb6-a485-c16585420eb017
314055isosorbide dinitrate 5 MG Oral TabletSCD6df6a2fa-c56c-4eb6-a485-c16585420eb017
381056ISDN 10 MG Oral TabletSY6df6a2fa-c56c-4eb6-a485-c16585420eb017
206842ISDN 20 MG Oral TabletSY6df6a2fa-c56c-4eb6-a485-c16585420eb017
197839ISDN 30 MG Oral TabletSY6df6a2fa-c56c-4eb6-a485-c16585420eb017
314055ISDN 5 MG Oral TabletSY6df6a2fa-c56c-4eb6-a485-c16585420eb017
381056isosorbide dinitrate 10 MG Oral TabletPSN5c94ecc0-fcaa-4af3-82c2-ff124f2df3e110
206842isosorbide dinitrate 20 MG Oral TabletPSN5c94ecc0-fcaa-4af3-82c2-ff124f2df3e110
381056isosorbide dinitrate 10 MG Oral TabletSCD5c94ecc0-fcaa-4af3-82c2-ff124f2df3e110
206842isosorbide dinitrate 20 MG Oral TabletSCD5c94ecc0-fcaa-4af3-82c2-ff124f2df3e110
381056ISDN 10 MG Oral TabletSY5c94ecc0-fcaa-4af3-82c2-ff124f2df3e110
206842ISDN 20 MG Oral TabletSY5c94ecc0-fcaa-4af3-82c2-ff124f2df3e110
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
49884-022-0149884002201100 TABLET in 1 BOTTLE (49884-022-01) 100 tablet1981-12-150000-00-00NoNoCurrent
49884-022-10498840022101000 TABLET in 1 BOTTLE (49884-022-10) 1000 tablet1981-12-150000-00-00NoNoCurrent