MedPath
FDA Approval

Univasc

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
UCB, Inc.
DUNS: 028526403
Effective Date
February 23, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Moexipril(15 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Univasc

Product Details

NDC Product Code
0091-3715
Application Number
NDA020312
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
February 23, 2016
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671PClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MoexiprilActive
Code: Q1UMG3UH45Class: ACTIBQuantity: 15 mg in 1 1

Univasc

Product Details

NDC Product Code
0091-3707
Application Number
NDA020312
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
February 23, 2016
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MoexiprilActive
Code: Q1UMG3UH45Class: ACTIBQuantity: 7.5 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671PClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
© Copyright 2025. All Rights Reserved by MedPath