Rx only · Tablet · Oral

Simvastatin

1 ACTIVE SUPPLIER — US

openFDA · updated weekly

US5 NDCs
1 active makers

UKComing
soon

CAComing
soon

AUComing
soon

EUComing
soon

RxCUI (US)36567

US makers1 labelers

Packages25

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.

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

Labeler	Type	Packages	Status
Micro Labs Limited	unknown	25	SUPPLYING

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

Dec 4, 2014
RECALLRecall (Class III): Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manu…
Failed Impurities/Degradation Specifications: Product failed a known impurity specification. — Recalling firm: Micro Labs Usa, Inc S — Nationwide.
Aug 19, 2014
RECALLRecall (Class III): Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Ma…
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification. — Recalling firm: Micro Labs Usa, Inc S — NY