Isosorbide Dinitrate

Product NDC
63739-569
11-digit product format
637390569
Labeler code
63739
Product ID
63739-569_ba72def9-e6f0-9846-e053-2a95a90aeb4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA086925
Marketing category
ANDA
Marketing start
1979-12-22
Marketing end
0000-00-00
Substance
ISOSORBIDE DINITRATE
Active strength
10 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-569-102020-07-22C16284748780-1ab0e2407-33a6-f274-e053-dbdaa90a6471b334fcb9-9b54-44f7-b708-82c13fbe2035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-569-10EA - Each63739-5699da56d96-cd02-4eb6-b7cc-ce1026a0035812015-12-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-569ISOSORBIDE DINITRATE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]15Legacy NDC20241228_b334fcb9-9b54-44f7-b708-82c13fbe2035.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-569-106373905691010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-569-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2015-11-300000-00-00NoNoCurrent