Labeler · US market

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC is a US drug labeler with US FDA registrations covering 32 drug concepts (32 currently active) across 85 packages. It is currently the only active US supplier of 1 drug. The company files with FDA under 2 name variants, merged into this profile.

Also files as: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

ACTIVE — US

openFDA · updated weekly

Labeler codes0168

Active drugs32

Registrations40 active / 40

Packages85

Sole supplier of1 drugs

Portfolio32 drugs · US

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

Drug	Type	NDCs	Packages	Status
Clobetasol Propionate cream	rx	2	7	SUPPLYING
Tacrolimus ointment	rx	2	6	SUPPLYING
Triamcinolone Acetonide cream	rx	3	6	SUPPLYING
Triamcinolone Acetonide ointment	rx	2	4	SUPPLYING
Clobetasol Propionate ointment	rx	1	4	SUPPLYING
Hydrocortisone cream	rx	2	4	SUPPLYING
Hydrocortisone ointment	rx	2	4	SUPPLYING
Lidocaine And Prilocaine cream	rx	1	3	SUPPLYING
Fluticasone Propionate cream	rx	1	3	SUPPLYING
Clotrimazole cream	rx	1	3	SUPPLYING
Clobetasol Propionate gel	rx	1	3	SUPPLYING
Ketoconazole cream	rx	1	3	SUPPLYING
Alclometasone Dipropionate cream	rx	1	3	SUPPLYING
Oxiconazole Nitrate cream	rx	1	3	SUPPLYING
Clotrimazole And Betamethasone Dipropionate cream	rx	1	2	SUPPLYING
Betamethasone Dipropionate ointment, augmented	rx	1	2	SUPPLYING
Betamethasone Dipropionate ointment	rx	1	2	SUPPLYING
Betamethasone Dipropionate lotion, augmented	rx	1	2	SUPPLYING
Betamethasone Dipropionate cream	rx	1	2	SUPPLYING
Clindamycin Phosphate solution	rx	1	2	SUPPLYING
Betamethasone Valerate ointment	rx	1	2	SUPPLYING
Clindamycin Phosphate gel	rx	1	2	SUPPLYING
Terconazole cream	rx	2	2	SUPPLYING
Fluocinolone Acetonide ointment	rx	1	2	SUPPLYING
Betamethasone Valerate cream	rx	1	2	SUPPLYING
Fluocinonide solution	rx	1	1	SUPPLYING
Adapalene cream	rx	1	1	SUPPLYING
Clindamycin Phosphate lotion	rx	1	1	SUPPLYING
Betamethasone Valerate lotion	rx	1	1	SUPPLYING
Betamethasone Dipropionate lotion	rx	1	1	SUPPLYING
Clindamycin Phosphate cream	rx	1	1	SUPPLYING
Clobetasol Propionate 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.

Betamethasone Valeraterx

At a glance

TypeLabeler
Labeler codes0168
Filing names2
Drugs (active)32
Drugs (all time)32
US registrations40
Packages85

Recent events

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

Apr 13, 2022
RECALLRecall (Class II): Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60
Apr 13, 2022
RECALLRecall (Class II): Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56
Apr 13, 2022
RECALLRecall (Class II): Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46
Apr 13, 2022
RECALLRecall (Class II): Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30
Apr 13, 2022
RECALLRecall (Class II): Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15

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.