Isosorbide Mononitrate

Product NDC
70518-3081
11-digit product format
705183081
Labeler code
70518
Product ID
70518-3081_c131a49d-4c8d-06c8-e053-2a95a90a1ef9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075037
Marketing category
ANDA
Marketing start
2021-04-30
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
20 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
70518-3081-02023-03-16C16284748780-1f386c649-a488-0266-e053-dadaa90a7c1a4e84dd07-f0ed-4c1a-a15f-8685ee110056
70518-3081-02023-01-30C16284748780-1f386c649-a488-0266-e053-dadaa90a7c1a4e84dd07-f0ed-4c1a-a15f-8685ee110056

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3081-07051830810090 TABLET in 1 BOTTLE, PLASTIC (70518-3081-0) 90 tablet2021-04-300000-00-00NoNoCurrent