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Quinapril Hydrochloride/Hydrochlorothiazide

Quinapril Hydrochloride/Hydrochlorothiazide Tablets

Approved
Approval ID

c3c8e14c-d226-4d2b-bfe5-9246bba86369

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 11, 2018

Manufacturers
FDA

Lake Erie Medical DBA Quality Care Products LLC

DUNS: 831276758

Products 1

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

Quinapril Hydrochloride/Hydrochlorothiazide

PRODUCT DETAILS

NDC Product Code35356-998
Application NumberANDA078450
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 11, 2018
Generic NameQuinapril Hydrochloride/Hydrochlorothiazide

INGREDIENTS (14)

FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
QUINAPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Quinapril Hydrochloride/Hydrochlorothiazide - FDA Drug Approval Details