Labeler · US market

SPIRIT PHARMACEUTICALS LLC

SPIRIT PHARMACEUTICALS LLC is a US drug labeler with US FDA registrations covering 7 drug concepts (7 currently active) across 26 packages. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Spirit Pharmaceutical LLC

ACTIVE — US

openFDA · updated weekly

Labeler codes68210

Active drugs7

Registrations16 active / 16

Packages26

Sole supplier of0 drugs

Portfolio7 drugs · US

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

Drug	Type	NDCs	Packages	Status
Ibuprofen tablet, film coated	rx	7	11	SUPPLYING
Cetirizine Hydrochloride tablet, film coated	otc	3	5	SUPPLYING
Dextromethorphan Hydrobromide capsule, liquid filled	other	1	5	SUPPLYING
Fexofenadine Hydrochloride tablet, film coated	otc	2	2	SUPPLYING
Loratadine tablet	rx	1	1	SUPPLYING
Naproxen Sodium tablet, film coated, extended release	rx	1	1	SUPPLYING
Ibuprofen capsule, liquid filled	otc	1	1	SUPPLYING

At a glance

TypeLabeler
Labeler codes68210
Filing names2
Drugs (active)7
Drugs (all time)7
US registrations16
Packages26

Recent events

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

Jun 16, 2021
RECALLRecall (Class II): Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentovill…
Jan 10, 2018
RECALLRecall (Class II): Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779…

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 (see “Also files as” above); figures cover the entity across all its filing names.