FDA.reportPublic FDA data

Quinapril

Product NDC
69097-841
11-digit product format
690970841
Labeler code
69097
Product ID
69097-841_56ce107f-65d9-4ec8-8859-6a256b27dc57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinapril
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA078457
Marketing category
ANDA
Marketing start
2016-07-22
Substance
QUINAPRIL HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
69097-841-05Quinapril90 in 1 BOTTLETABLET905
69097-841-15Quinapril1000 in 1 BOTTLETABLET10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-841QUINAPRIL TABLET [CIPLA USA INC.]5Current NDC, Legacy NDC, 2 package rows20230121_e6d36e1e-8e35-4d06-83dc-45e0456365fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312748quinapril HCl 10 MG Oral TabletPSNe6d36e1e-8e35-4d06-83dc-45e0456365fd5
312749quinapril HCl 20 MG Oral TabletPSNe6d36e1e-8e35-4d06-83dc-45e0456365fd5
314203quinapril HCl 40 MG Oral TabletPSNe6d36e1e-8e35-4d06-83dc-45e0456365fd5
312750quinapril HCl 5 MG Oral TabletPSNe6d36e1e-8e35-4d06-83dc-45e0456365fd5
312748quinapril 10 MG Oral TabletSCDe6d36e1e-8e35-4d06-83dc-45e0456365fd5
312749quinapril 20 MG Oral TabletSCDe6d36e1e-8e35-4d06-83dc-45e0456365fd5
314203quinapril 40 MG Oral TabletSCDe6d36e1e-8e35-4d06-83dc-45e0456365fd5
312750quinapril 5 MG Oral TabletSCDe6d36e1e-8e35-4d06-83dc-45e0456365fd5
312748quinapril (as quinapril HCl) 10 MG Oral TabletSYe6d36e1e-8e35-4d06-83dc-45e0456365fd5
312749quinapril (as quinapril HCl) 20 MG Oral TabletSYe6d36e1e-8e35-4d06-83dc-45e0456365fd5
314203quinapril (as quinapril hydrochloride) 40 MG Oral TabletSYe6d36e1e-8e35-4d06-83dc-45e0456365fd5
312750quinapril (as quinapril hydrochloride) 5 MG Oral TabletSYe6d36e1e-8e35-4d06-83dc-45e0456365fd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-841-056909708410590 TABLET in 1 BOTTLE (69097-841-05) 90 tablet2016-07-220000-00-00NoNoCurrent
69097-841-15690970841151000 TABLET in 1 BOTTLE (69097-841-15) 1000 tablet2016-07-220000-00-00NoNoCurrent