Isosorbide Dinitrate

Product NDC
53808-0626
11-digit product format
538080626
Labeler code
53808
Product ID
53808-0626_bd1688e6-8f0a-4238-bf1a-ecd770bb6496
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA089367
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
ISOSORBIDE DINITRATE
Active strength
20 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
53808-0626-22020-01-31C16284748780-19d75b9d0-7b9d-f424-e053-dadaa90a57ceIsosorbide Dinitrate Tablets, USP (Oral)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0626-2Isosorbide Dinitrate60 in 1 BLISTER PACKTABLET601

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0626ISOSORBIDE DINITRATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_9c6a10ba-04a5-4d7e-83fb-d0001d547496.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206842isosorbide dinitrate 20 MG Oral TabletPSN9c6a10ba-04a5-4d7e-83fb-d0001d5474961
206842isosorbide dinitrate 20 MG Oral TabletSCD9c6a10ba-04a5-4d7e-83fb-d0001d5474961
206842ISDN 20 MG Oral TabletSY9c6a10ba-04a5-4d7e-83fb-d0001d5474961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0626-25380806260260 in 1 BLISTER PACKHistorical