Isosorbide Mononitrate

Product NDC
50090-7038
11-digit product format
500907038
Labeler code
50090
Product ID
50090-7038_89d60363-3bdb-48ce-b0ba-88b8a962bb2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210918
Marketing category
ANDA
Marketing start
2018-11-13
Substance
ISOSORBIDE MONONITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
LX1OH63030ISOSORBIDE MONONITRATE16051-77-7ISOSORBIDE MONONITRATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7038-05009070380090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7038-0) 2024-01-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Isosorbide Mononitrate Extended-Release Tablets, USPA-S Medication Solutions2024-01-23HUMAN PRESCRIPTION DRUG LABEL1