Labeler · US market

Burel Pharmaceuticals, LLC

Burel Pharmaceuticals, LLC is a US drug labeler with US FDA registrations covering 16 drug concepts (15 currently active) across 36 packages.

ACTIVE — US

openFDA · updated weekly

Labeler codes35573

Active drugs15

Registrations24 active / 30

Packages36

Sole supplier of0 drugs

Portfolio16 drugs · US

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

Drug	Type	NDCs	Packages	Status
Tadalafil tablet, film coated	rx	4	4	SUPPLYING
Benzoyl Peroxide liquid	otc	2	4	SUPPLYING
Levalbuterol Hydrochloride solution	rx	3	3	SUPPLYING
Betamethasone Dipropionate ointment, augmented	rx	1	2	SUPPLYING
Nicardipine Hydrochloride capsule	rx	2	2	SUPPLYING
Leflunomide tablet, film coated	rx	2	2	SUPPLYING
Ketoconazole tablet	rx	1	2	SUPPLYING
Butalbital And Acetaminophen tablet	rx	2	2	SUPPLYING
Clomiphene Citrate tablet	rx	1	2	SUPPLYING
Sodium Polystyrene Sulfonate suspension	rx	1	2	SUPPLYING
Phenoxybenzamine Hydrochloride capsule	rx	1	1	SUPPLYING
Finasteride tablet, film coated	rx	1	1	SUPPLYING
Pantoprazole Sodium tablet, delayed release	rx	1	1	SUPPLYING
Sodium Fluoride gel, dentifrice	rx	1	1	SUPPLYING
Carglumic Acid tablet, for suspension	rx	1	1	SUPPLYING
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate capsule, extended release	rx	6	6	DISCONTINUED

At a glance

TypeLabeler
Labeler codes35573
Filing names1
Drugs (active)15
Drugs (all time)16
US registrations30
Packages36

Recent events

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

Oct 24, 2016
RECALLRecall (Class II): Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals…
Oct 24, 2016
RECALLRecall (Class II): AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg,…
Oct 24, 2016
RECALLRecall (Class II): UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosp…
Oct 24, 2016
RECALLRecall (Class II): Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methen…
Oct 24, 2016
RECALLRecall (Class II): Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Ph…
Oct 24, 2016
RECALLRecall (Class II): UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicyla…
Oct 24, 2016
RECALLRecall (Class II): Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals…
Oct 24, 2016
RECALLRecall (Class II): URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, …

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.