FDA.reportPublic FDA data

Quinapril

Product NDC
63304-551
11-digit product format
633040551
Labeler code
63304
Product ID
63304-551_fbea9a22-e8f7-43c6-9a85-9e49aef6affd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quinapril
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076607
Marketing category
ANDA
Marketing start
2007-09-24
Marketing end
0000-00-00
Substance
QUINAPRIL HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9992a562-005f-c280-535c-2e4eaa81efcdProduct name220161121
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63304-551-102020-01-31C16284748780-19d75b9cf-d05b-f424-e053-dadaa90a57ceQUINAPRIL TABLETS, USP
63304-551-302020-01-31C16284748780-19d75b9cf-d05b-f424-e053-dadaa90a57ceQUINAPRIL TABLETS, USP
63304-551-902020-01-31C16284748780-19d75b9cf-d05b-f424-e053-dadaa90a57ceQUINAPRIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-551-10Quinapril1000 in 1 BOTTLETABLET, FILM COATED10009
63304-551-30Quinapril30 in 1 BOTTLETABLET, FILM COATED309
63304-551-90Quinapril90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-551-90EA - Each63304-5514d40081d-5b8c-4d9e-bcdd-36c9df88f6b912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUINAPRIL HYDROCHLORIDEACTIVE INGREDIENT33067B3N2MQUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
QUINAPRILATACTIVE MOIETY34SSX5LDE5QUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKQUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62QUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAQUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990QUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UQUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEQUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]8
QUINAPRIL HYDROCHLORIDEACTIVE INGREDIENT33067B3N2MQUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
QUINAPRILACTIVE MOIETYRJ84Y44811QUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKQUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62QUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAQUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990QUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EQUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UQUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEQUINAPRIL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-551QUINAPRIL TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]9Legacy NDC, 3 package rows20151203_f125a336-5c35-4e64-86fe-5c6d1a9295e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312748quinapril HCl 10 MG Oral TabletPSNf125a336-5c35-4e64-86fe-5c6d1a9295e19
312749quinapril HCl 20 MG Oral TabletPSNf125a336-5c35-4e64-86fe-5c6d1a9295e19
314203quinapril HCl 40 MG Oral TabletPSNf125a336-5c35-4e64-86fe-5c6d1a9295e19
312750quinapril HCl 5 MG Oral TabletPSNf125a336-5c35-4e64-86fe-5c6d1a9295e19
312748quinapril 10 MG Oral TabletSCDf125a336-5c35-4e64-86fe-5c6d1a9295e19
312749quinapril 20 MG Oral TabletSCDf125a336-5c35-4e64-86fe-5c6d1a9295e19
314203quinapril 40 MG Oral TabletSCDf125a336-5c35-4e64-86fe-5c6d1a9295e19
312750quinapril 5 MG Oral TabletSCDf125a336-5c35-4e64-86fe-5c6d1a9295e19
312748quinapril (as quinapril HCl) 10 MG Oral TabletSYf125a336-5c35-4e64-86fe-5c6d1a9295e19
312749quinapril (as quinapril HCl) 20 MG Oral TabletSYf125a336-5c35-4e64-86fe-5c6d1a9295e19
314203quinapril (as quinapril hydrochloride) 40 MG Oral TabletSYf125a336-5c35-4e64-86fe-5c6d1a9295e19
312750quinapril (as quinapril hydrochloride) 5 MG Oral TabletSYf125a336-5c35-4e64-86fe-5c6d1a9295e19
312748quinapril HCl 10 MG Oral TabletPSN4908849a-c727-49a6-b936-e9d935374d742
312749quinapril HCl 20 MG Oral TabletPSN4908849a-c727-49a6-b936-e9d935374d742
314203quinapril HCl 40 MG Oral TabletPSN4908849a-c727-49a6-b936-e9d935374d742
312750quinapril HCl 5 MG Oral TabletPSN4908849a-c727-49a6-b936-e9d935374d742
312748quinapril 10 MG Oral TabletSCD4908849a-c727-49a6-b936-e9d935374d742
312749quinapril 20 MG Oral TabletSCD4908849a-c727-49a6-b936-e9d935374d742
314203quinapril 40 MG Oral TabletSCD4908849a-c727-49a6-b936-e9d935374d742
312750quinapril 5 MG Oral TabletSCD4908849a-c727-49a6-b936-e9d935374d742
312748quinapril (as quinapril HCl) 10 MG Oral TabletSY4908849a-c727-49a6-b936-e9d935374d742
312749quinapril (as quinapril HCl) 20 MG Oral TabletSY4908849a-c727-49a6-b936-e9d935374d742
314203quinapril (as quinapril hydrochloride) 40 MG Oral TabletSY4908849a-c727-49a6-b936-e9d935374d742
312750quinapril (as quinapril hydrochloride) 5 MG Oral TabletSY4908849a-c727-49a6-b936-e9d935374d742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-551-10633040551101000 in 1 BOTTLEHistorical
63304-551-306330405513030 in 1 BOTTLEHistorical
63304-551-906330405519090 in 1 BOTTLEHistorical