Isosorbide Mononitrate

Product NDC
70518-2207
11-digit product format
705182207
Labeler code
70518
Product ID
70518-2207_daf9d644-7a02-7169-e053-2a95a90aad78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075522
Marketing category
ANDA
Marketing start
2019-07-11
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
60 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2207-07051822070090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2207-0) 2019-07-110000-00-00NoNoCurrent