Univasc
univasc tablets (moexipril hydrochloride)
Approved
Approval ID
e16c2ad3-1ce5-48fc-96b2-5d63dc6b68d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2016
Manufacturers
FDA
UCB, Inc.
DUNS: 028526403
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
moexipril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0091-3715
Application NumberNDA020312
Product Classification
M
Marketing Category
C73594
G
Generic Name
moexipril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 23, 2016
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MOEXIPRIL HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: Q1UMG3UH45
Classification: ACTIB
moexipril hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0091-3707
Application NumberNDA020312
Product Classification
M
Marketing Category
C73594
G
Generic Name
moexipril hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 23, 2016
FDA Product Classification
INGREDIENTS (11)
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MOEXIPRIL HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: Q1UMG3UH45
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT