FDA.reportPublic FDA data

Quinapril HCL and Hydrochlorothiazide

Product NDC
43386-711
11-digit product format
433860711
Labeler code
43386
Product ID
43386-711_916f3e69-0d6e-4524-8abe-afb2e134eec2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinapril HCL and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA076374
Marketing category
ANDA
Marketing start
2011-07-15
Substance
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Active strength
12.5; 20 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
QUINAPRIL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, 33067B3N2M
Rxcui310796, 310797, 310809

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
9992a562-005f-c280-535c-2e4eaa81efcdProduct name220161121
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-711-03Quinapril HCL and Hydrochlorothiazide30 in 1 BOTTLETABLET309
43386-711-05Quinapril HCL and Hydrochlorothiazide500 in 1 BOTTLETABLET5009
43386-711-09Quinapril HCL and Hydrochlorothiazide90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-711-05EA - Each43386-711f2fdb515-c3cc-4404-bfd1-e5733c3d80b612012-07-24
43386-711-09EA - Each43386-7119d2ca1ed-9907-4bc5-b5e2-7c091a0c5ee612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
QUINAPRIL HYDROCHLORIDEACTIVE INGREDIENT33067B3N2MQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
QUINAPRILATACTIVE MOIETY34SSX5LDE5QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEQUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-711QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS,INC.]9Current NDC, Legacy NDC, 3 package rows20240131_383ecaa6-29c8-4280-a442-c47f101d7c88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310796quinapril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN383ecaa6-29c8-4280-a442-c47f101d7c889
310797quinapril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN383ecaa6-29c8-4280-a442-c47f101d7c889
310809quinapril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN383ecaa6-29c8-4280-a442-c47f101d7c889
310796hydrochlorothiazide 12.5 MG / quinapril 10 MG Oral TabletSCD383ecaa6-29c8-4280-a442-c47f101d7c889
310797hydrochlorothiazide 12.5 MG / quinapril 20 MG Oral TabletSCD383ecaa6-29c8-4280-a442-c47f101d7c889
310809hydrochlorothiazide 25 MG / quinapril 20 MG Oral TabletSCD383ecaa6-29c8-4280-a442-c47f101d7c889
310796HCTZ 12.5 MG / quinapril (as quinapril hydrochloride) 10 MG Oral TabletSY383ecaa6-29c8-4280-a442-c47f101d7c889
310797HCTZ 12.5 MG / quinapril (as quinapril hydrochloride) 20 MG Oral TabletSY383ecaa6-29c8-4280-a442-c47f101d7c889
310796HCTZ 12.5 MG / quinapril 10 MG Oral TabletSY383ecaa6-29c8-4280-a442-c47f101d7c889
310797HCTZ 12.5 MG / quinapril 20 MG Oral TabletSY383ecaa6-29c8-4280-a442-c47f101d7c889
310809HCTZ 25 MG / quinapril (as quinapril hydrochloride) 20 MG Oral TabletSY383ecaa6-29c8-4280-a442-c47f101d7c889
310809HCTZ 25 MG / quinapril 20 MG Oral TabletSY383ecaa6-29c8-4280-a442-c47f101d7c889

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-711-034338607110330 TABLET in 1 BOTTLE (43386-711-03) 30 tablet2012-06-180000-00-00NoNoCurrent
43386-711-0543386071105500 TABLET in 1 BOTTLE (43386-711-05) 500 tablet2011-07-150000-00-00NoNoCurrent
43386-711-094338607110990 TABLET in 1 BOTTLE (43386-711-09) 90 tablet2011-07-150000-00-00NoNoCurrent