FDA.reportPublic FDA data

QUINAPRIL

Product NDC
43547-413
11-digit product format
435470413
Labeler code
43547
Product ID
43547-413_b8f1731a-cbac-4f64-a8d4-320b80b335e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quinapril
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA205823
Marketing category
ANDA
Marketing start
2016-03-16
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43547-413-092020-03-10C16284748780-19d75b9d0-9a9c-f424-e053-dadaa90a57ceQuinapril Tablets, USP
43547-413-092020-01-31C16284748780-19d75b9d0-9a9c-f424-e053-dadaa90a57ceQuinapril Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-413-09QUINAPRIL90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-413-09EA - Each43547-4133997c9bb-97b0-4aae-bf1c-553ec70e594012018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-413QUINAPRIL TABLET [SOLCO HEALTHCARE US, LLC]5Current NDC, Legacy NDC, 1 package rows20231118_cd46691d-5593-4a9f-a937-999c6803e312.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314203quinapril HCl 40 MG Oral TabletPSN574cc7ec-537d-42db-8af8-432e6d842aea100
314203quinapril 40 MG Oral TabletSCD574cc7ec-537d-42db-8af8-432e6d842aea100
314203quinapril (as quinapril hydrochloride) 40 MG Oral TabletSY574cc7ec-537d-42db-8af8-432e6d842aea100
312748quinapril HCl 10 MG Oral TabletPSNcd46691d-5593-4a9f-a937-999c6803e3125
312749quinapril HCl 20 MG Oral TabletPSNcd46691d-5593-4a9f-a937-999c6803e3125
314203quinapril HCl 40 MG Oral TabletPSNcd46691d-5593-4a9f-a937-999c6803e3125
312750quinapril HCl 5 MG Oral TabletPSNcd46691d-5593-4a9f-a937-999c6803e3125
312748quinapril 10 MG Oral TabletSCDcd46691d-5593-4a9f-a937-999c6803e3125
312749quinapril 20 MG Oral TabletSCDcd46691d-5593-4a9f-a937-999c6803e3125
314203quinapril 40 MG Oral TabletSCDcd46691d-5593-4a9f-a937-999c6803e3125
312750quinapril 5 MG Oral TabletSCDcd46691d-5593-4a9f-a937-999c6803e3125
312748quinapril (as quinapril HCl) 10 MG Oral TabletSYcd46691d-5593-4a9f-a937-999c6803e3125
312749quinapril (as quinapril HCl) 20 MG Oral TabletSYcd46691d-5593-4a9f-a937-999c6803e3125
314203quinapril (as quinapril hydrochloride) 40 MG Oral TabletSYcd46691d-5593-4a9f-a937-999c6803e3125
312750quinapril (as quinapril hydrochloride) 5 MG Oral TabletSYcd46691d-5593-4a9f-a937-999c6803e3125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-413-094354704130990 TABLET in 1 BOTTLE (43547-413-09) 90 tablet2017-11-100000-00-00NoNoCurrent