Isosorbide Mononitrate

Product NDC
70518-2692
11-digit product format
705182692
Labeler code
70518
Product ID
70518-2692_d6e5b6d8-12d2-17ad-e053-2a95a90a04a4
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
2020-04-15
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
30 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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2692-07051826920090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2692-0) 2020-04-150000-00-00NoNoCurrent
70518-2692-17051826920130 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2692-1) 2020-05-060000-00-00NoNoCurrent