MedPath

Quinapril

QUINAPRIL TABLETS, USP

Approved
Approval ID

f125a336-5c35-4e64-86fe-5c6d1a9295e1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2015

Manufacturers
FDA

Ranbaxy Pharmaceuticals Inc.

DUNS: 937890044

Products 4

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

quinapril

PRODUCT DETAILS

NDC Product Code63304-550
Application NumberANDA076607
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 5, 2015
Generic Namequinapril

INGREDIENTS (11)

QUINAPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

quinapril

PRODUCT DETAILS

NDC Product Code63304-551
Application NumberANDA076607
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 5, 2015
Generic Namequinapril

INGREDIENTS (11)

QUINAPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

quinapril

PRODUCT DETAILS

NDC Product Code63304-549
Application NumberANDA076607
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 5, 2015
Generic Namequinapril

INGREDIENTS (11)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
QUINAPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

quinapril

PRODUCT DETAILS

NDC Product Code63304-548
Application NumberANDA076607
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 5, 2015
Generic Namequinapril

INGREDIENTS (11)

QUINAPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 33067B3N2M
Classification: ACTIR
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT

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Quinapril - FDA Drug Approval Details