Quinapril

Product NDC
65862-620
11-digit product format
658620620
Labeler code
65862
Product ID
65862-620_5263abd5-ce46-4918-9bb0-9632861bcbc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinapril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202725
Marketing category
ANDA
Marketing start
2013-04-29
Substance
QUINAPRIL HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quinapril
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUINAPRIL HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33067B3N2M
Rxcui312748, 312749, 312750, 314203

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-620-10Quinapril10 in 1 BLISTER PACKTABLET, FILM COATED1014
65862-620-30Quinapril30 in 1 BOTTLETABLET, FILM COATED3014
65862-620-39Quinapril3000 in 1 BOTTLETABLET, FILM COATED300014
65862-620-78Quinapril10 in 1 CARTONTABLET, FILM COATED1014
65862-620-90Quinapril90 in 1 BOTTLETABLET, FILM COATED9014
65862-620-99Quinapril1000 in 1 BOTTLETABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-620-90EA - Each65862-620b46a0d9c-96f6-4fc7-a9cc-14cfe927ebd712013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUINAPRIL HYDROCHLORIDEACTIVE INGREDIENT33067B3N2MQUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
QUINAPRILATACTIVE MOIETY34SSX5LDE5QUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKQUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675QUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PQUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82QUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NQUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAQUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQQUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XQUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-620QUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 6 package rows20240517_93e6e668-5306-4f26-81d8-cbc3a7a5e787.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312749quinapril HCl 20 MG Oral TabletPSN913c359f-160c-4cd9-88f7-ae1c74340e4921
314203quinapril HCl 40 MG Oral TabletPSN913c359f-160c-4cd9-88f7-ae1c74340e4921
312749quinapril 20 MG Oral TabletSCD913c359f-160c-4cd9-88f7-ae1c74340e4921
314203quinapril 40 MG Oral TabletSCD913c359f-160c-4cd9-88f7-ae1c74340e4921
312749quinapril (as quinapril HCl) 20 MG Oral TabletSY913c359f-160c-4cd9-88f7-ae1c74340e4921
314203quinapril (as quinapril hydrochloride) 40 MG Oral TabletSY913c359f-160c-4cd9-88f7-ae1c74340e4921
312748quinapril HCl 10 MG Oral TabletPSN93e6e668-5306-4f26-81d8-cbc3a7a5e78714
312749quinapril HCl 20 MG Oral TabletPSN93e6e668-5306-4f26-81d8-cbc3a7a5e78714
314203quinapril HCl 40 MG Oral TabletPSN93e6e668-5306-4f26-81d8-cbc3a7a5e78714
312750quinapril HCl 5 MG Oral TabletPSN93e6e668-5306-4f26-81d8-cbc3a7a5e78714
312748quinapril 10 MG Oral TabletSCD93e6e668-5306-4f26-81d8-cbc3a7a5e78714
312749quinapril 20 MG Oral TabletSCD93e6e668-5306-4f26-81d8-cbc3a7a5e78714
314203quinapril 40 MG Oral TabletSCD93e6e668-5306-4f26-81d8-cbc3a7a5e78714
312750quinapril 5 MG Oral TabletSCD93e6e668-5306-4f26-81d8-cbc3a7a5e78714
312748quinapril (as quinapril HCl) 10 MG Oral TabletSY93e6e668-5306-4f26-81d8-cbc3a7a5e78714
312749quinapril (as quinapril HCl) 20 MG Oral TabletSY93e6e668-5306-4f26-81d8-cbc3a7a5e78714
314203quinapril (as quinapril hydrochloride) 40 MG Oral TabletSY93e6e668-5306-4f26-81d8-cbc3a7a5e78714
312750quinapril (as quinapril hydrochloride) 5 MG Oral TabletSY93e6e668-5306-4f26-81d8-cbc3a7a5e78714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-620-106586206201010 in 1 BLISTER PACKHistorical
65862-620-306586206203030 TABLET, FILM COATED in 1 BOTTLE (65862-620-30) 2013-04-290000-00-00NoNoCurrent
65862-620-39658620620393000 TABLET, FILM COATED in 1 BOTTLE (65862-620-39) 2013-04-290000-00-00NoNoCurrent
65862-620-49658620620494000 TABLET, FILM COATED in 1 BAG (65862-620-49)29-APR-13Current
65862-620-786586206207810 BLISTER PACK in 1 CARTON (65862-620-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-620-10) 10 blister pack2013-04-290000-00-00NoNoCurrent
65862-620-906586206209090 TABLET, FILM COATED in 1 BOTTLE (65862-620-90) 2013-04-290000-00-00NoNoCurrent
65862-620-99658620620991000 TABLET, FILM COATED in 1 BOTTLE (65862-620-99) 2013-04-290000-00-00NoNoCurrent