Isosorbide Dinitrate

Product NDC
70518-0063
11-digit product format
705180063
Labeler code
70518
Product ID
70518-0063_e649df04-0fbc-27f7-e053-2a95a90a3ab3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA086223
Marketing category
ANDA
Marketing start
2016-12-14
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
70518-0063-07051800630030 TABLET in 1 BLISTER PACK (70518-0063-0) 30 tablet2016-12-140000-00-00NoNoCurrent
70518-0063-17051800630190 TABLET in 1 BOTTLE, PLASTIC (70518-0063-1) 90 tablet2019-07-100000-00-00NoNoCurrent