Quinapril

Quinapril Hydrochloride

7 ACTIVE SUPPLIERS — US

openFDA · updated weekly

US23 NDCs
7 active makers

UKComing
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CAComing
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AUComing
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EUComing
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ATCC09AA06

RxCUI (US)35208

US makers7 labelers

Packages29

DEA / ScheduleNone

Medicaid dispensing volume

No Medicaid utilization on record for this drug concept yet. Quarterly volume (CMS State Drug Utilization Data) loads with the utilization ETL.

Who makes it7 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

Labeler	Type	Packages	Status
Proficient Rx LP	unknown	9	SUPPLYING
Cipla USA Inc.	unknown	8	SUPPLYING
SOLCO HEALTHCARE US, LLC	unknown	4

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

Jan 19, 2023
SHORTAGEDrug shortage: Quinapril Hydrochloride Tablet (Lupin Pharmaceuticals, Inc.)
Quinapril Hydrochloride Tablet — reported in shortage by Lupin Pharmaceuticals, Inc.. Therapeutic category: Cardiovascular.
Jan 19, 2023
SHORTAGEDrug shortage: Quinapril Hydrochloride Tablet (Solco Healthcare US, LLC)
Quinapril Hydrochloride Tablet — reported in shortage by Solco Healthcare US, LLC. Therapeutic category: Cardiovascular.
Dec 7, 2022
RECALLRecall (Class II): Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 2120…
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed by major distribution chains nationwide.
Dec 7, 2022
RECALLRecall (Class II): Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 2120…
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. — Recalling firm: Lupin Pharmaceuticals Inc. — Product was distributed by major distribution chains nationwide.
Dec 7, 2015
RECALLRecall (Class III): Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
Failed Impurities/Degradation Specifications; Impurity A — Recalling firm: Lupin Pharmaceuticals Inc. — Nationwide
Sep 17, 2013
RECALLRecall (Class II): Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21…
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval — Recalling firm: Lupin Pharmaceuticals Inc. — Nationwide and Puerto Rico
Sep 17, 2013
RECALLRecall (Class II): Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 2…
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval — Recalling firm: Lupin Pharmaceuticals Inc. — Nationwide and Puerto Rico