Quinapril
Quinapril Tablets, USP Rx only
Approved
Approval ID
913c359f-160c-4cd9-88f7-ae1c74340e49
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quinapril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-2117
Application NumberANDA202725
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2020
FDA Product Classification
INGREDIENTS (13)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
Quinapril Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-2116
Application NumberANDA202725
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinapril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2020
FDA Product Classification
INGREDIENTS (13)
QUINAPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT