FDA.reportPublic FDA data

Quinapril

Product NDC
63187-874
11-digit product format
631870874
Labeler code
63187
Product ID
63187-874_47f95e90-75fb-4294-b861-9a2349a48e91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinapril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202725
Marketing category
ANDA
Marketing start
2013-04-29
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

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
63187-874-30Quinapril30 in 1 BOTTLETABLET, FILM COATED304
63187-874-60Quinapril60 in 1 BOTTLETABLET, FILM COATED604
63187-874-90Quinapril90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-874-30EA - Each63187-874a1ee8b29-d273-41a0-bd7c-74a8fae9548212017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-874QUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20200320_42e4f9dd-6032-4257-bd0f-8e9b71027f03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312748quinapril HCl 10 MG Oral TabletPSN42e4f9dd-6032-4257-bd0f-8e9b71027f034
312748quinapril 10 MG Oral TabletSCD42e4f9dd-6032-4257-bd0f-8e9b71027f034
312748quinapril (as quinapril HCl) 10 MG Oral TabletSY42e4f9dd-6032-4257-bd0f-8e9b71027f034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-874-306318708743030 TABLET, FILM COATED in 1 BOTTLE (63187-874-30) 2017-08-010000-00-00NoNoCurrent
63187-874-606318708746060 TABLET, FILM COATED in 1 BOTTLE (63187-874-60) 2017-08-010000-00-00NoNoCurrent
63187-874-906318708749090 TABLET, FILM COATED in 1 BOTTLE (63187-874-90) 2017-08-010000-00-00NoNoCurrent