Isosorbide Mononitrate

Product NDC
63187-700
11-digit product format
631870700
Labeler code
63187
Product ID
63187-700_b2212d27-a0f7-48a6-ac0c-6e1ae378cb18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090598
Marketing category
ANDA
Marketing start
2010-08-11
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
2020-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-700-306318707003030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-700-30) 2016-05-020000-00-00NoNoCurrent
63187-700-606318707006060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-700-60) 2016-05-020000-00-00NoNoCurrent
63187-700-906318707009090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-700-90) 2016-05-020000-00-00NoNoCurrent