Isosorbide Mononitrate

Product NDC
70518-1485
11-digit product format
705181485
Labeler code
70518
Product ID
70518-1485_e454a69d-634f-57a0-e053-2a95a90a950d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075037
Marketing category
ANDA
Marketing start
2018-10-08
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
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
70518-1485-07051814850030 TABLET in 1 BLISTER PACK (70518-1485-0) 30 tablet2018-10-080000-00-00NoNoCurrent
70518-1485-17051814850190 TABLET in 1 BOTTLE, PLASTIC (70518-1485-1) 90 tablet2020-01-070000-00-00NoNoCurrent