Isosorbide Dinitrate

Product NDC
70518-1435
11-digit product format
705181435
Labeler code
70518
Product ID
70518-1435_e42aa3cc-2db8-199d-e053-2a95a90a70d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA086066
Marketing category
ANDA
Marketing start
2018-09-25
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1435-07051814350030 TABLET in 1 BLISTER PACK (70518-1435-0) 30 tablet2018-09-250000-00-00NoNoCurrent
70518-1435-17051814350190 TABLET in 1 BOTTLE, PLASTIC (70518-1435-1) 90 tablet2020-04-200000-00-00NoNoCurrent