Labeler · US market

Wockhardt USA LLC.

Wockhardt USA LLC. is a US drug labeler with US FDA registrations covering 2 drug concepts (2 currently active) across 3 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes64679

Active drugs2

Registrations3 active / 3

Packages3

Sole supplier of1 drugs

Portfolio2 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Oxacillin injection, powder, for solution	rx	2	2	SUPPLYING
Oxacillin injection, powder, for solution	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Oxacillinrx

At a glance

TypeLabeler
Labeler codes64679
Filing names1
Drugs (active)2
Drugs (all time)2
US registrations3
Packages3

Recent events

Shortages, recalls, and registration changes across all filing names.

Aug 22, 2017
RECALLRecall (Class III): Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. A…
Jul 29, 2015
RECALLRecall (Class II): Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distribut…
Jul 29, 2015
RECALLRecall (Class II): Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distribu…
Apr 22, 2015
RECALLRecall (Class II): Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 5…
Apr 22, 2015
RECALLRecall (Class II): Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC:…
Apr 22, 2015
RECALLRecall (Class II): Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufact…
Apr 22, 2015
RECALLRecall (Class II): Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottle…
Apr 22, 2015
RECALLRecall (Class II): Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumba…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.