isosorbide mononitrate

Product NDC
70518-3132
11-digit product format
705183132
Labeler code
70518
Product ID
70518-3132_c54908e4-10ed-3fc0-e053-2995a90afd3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075155
Marketing category
ANDA
Marketing start
2021-06-18
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3132-02023-03-17C16284748780-1f386c64a-0961-0266-e053-dadaa90a7c1a3dc0c26e-991b-4ca0-9dda-07336c6643e9
70518-3132-02023-01-30C16284748780-1f386c64a-0961-0266-e053-dadaa90a7c1a3dc0c26e-991b-4ca0-9dda-07336c6643e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3132-07051831320090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3132-0) 2021-06-180000-00-00NoNoCurrent