Is Acella Pharmaceuticals, LLC FDA approved?

Acella Pharmaceuticals, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Acella Pharmaceuticals, LLC's drugs manufactured?

The FDA register lists Alpharetta, GA. Registered operations: finished drug manufacture, relabelling, repackaging.

What drugs does Acella Pharmaceuticals, LLC make?

38 products are listed under Acella Pharmaceuticals, LLC in the openFDA NDC Directory, most often as tablet; liquid; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Acella Pharmaceuticals, LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 38
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Finished drug manufacture1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Acella Pharmaceuticals, LLC	1880 McFarland Pkwy Ste 110, Alpharetta, Georgia (GA) 30005, United States (USA)	Finished drug manufacture, Relabelling, Repackaging	3006691461825380939

Catalogue

Drug listings by form and route

38 active NDC listings: 38 human prescription drug. By marketing category: UNAPPROVED DRUG OTHER 29, ANDA 7, NDA 1, NDA AUTHORIZED GENERIC 1.

Dosage form	NDCs
tablet	8
liquid	5
solution	5
cream	4
capsule, gelatin coated	3
kit	2
rinse	2
syrup	2
capsule, coated	1
gel	1
injection	1
suspension	1
tablet, coated	1
tablet, film coated	1
tablet, orally disintegrating	1

Route	NDCs
oral	19
topical	15
intramuscular	1
intravenous	1
sublingual	1

Labeller name on the listing	NDCs
acella pharmaceuticals, llc	36
acella pharmaceuticals	1
acella pharmaceuticals	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
BP Vit 3	folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and .beta.-sitosterol	capsule, coated, oral	42192-301UNAPPROVED DRUG OTHER
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	syrup, oral	42192-607ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide	syrup, oral	42192-630ANDA
Ciclopirox	Ciclopirox	kit	42192-714UNAPPROVED DRUG OTHER
Ciclopirox	Ciclopirox	solution, topical	42192-715ANDA
Doxycycline	Doxycycline hyclate	tablet, coated, oral	42192-501ANDA
Gabapentin	gabapentin	solution, oral	42192-608ANDA
HYDROQUINONE 4%	Hydroquinone	cream, topical	42192-151UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate ODT	hyoscyamine sulfate	tablet, orally disintegrating, oral	42192-338UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate SL	hyoscyamine sulfate	tablet, sublingual	42192-339UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate TAB	hyoscyamine sulfate	tablet, oral	42192-340UNAPPROVED DRUG OTHER
NP Thyroid 120	LEVOTHYROXINE, LIOTHYRONINE	tablet, oral	42192-328UNAPPROVED DRUG OTHER
NP Thyroid 15	LEVOTHYROXINE, LIOTHYRONINE	tablet, oral	42192-327UNAPPROVED DRUG OTHER
NP Thyroid 30	LEVOTHYROXINE, LIOTHYRONINE	tablet, oral	42192-329UNAPPROVED DRUG OTHER
NP Thyroid 60	LEVOTHYROXINE, LIOTHYRONINE	tablet, oral	42192-330UNAPPROVED DRUG OTHER
NP Thyroid 90	LEVOTHYROXINE, LIOTHYRONINE	tablet, oral	42192-331UNAPPROVED DRUG OTHER
Naproxen	Naproxen	suspension, oral	42192-619NDA AUTHORIZED GENERIC
Nicotinamide	Nicotinamide	tablet, oral	42192-374UNAPPROVED DRUG OTHER
PHENYTOIN SODIUM	PHENYTOIN SODIUM	injection, intramuscular, intravenous	42192-614ANDA
PNV-DHA	ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent	capsule, gelatin coated, oral	42192-321UNAPPROVED DRUG OTHER
PNV-DHA	ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent	capsule, gelatin coated, oral	42192-323UNAPPROVED DRUG OTHER
PNV-Omega	ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium corbonate, ferrous fumarate, potassium iodide, magnesium, doconexent, icosapent	capsule, gelatin coated, oral	42192-332UNAPPROVED DRUG OTHER
PNV-Select	VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE and CUPRIC OXIDE	tablet, film coated, oral	42192-320UNAPPROVED DRUG OTHER
Pyridostigmine Bromide	pyridostigmine bromide	solution, oral	42192-626ANDA
SALICYLIC ACID	SALICYLIC ACID	liquid, topical	42192-135UNAPPROVED DRUG OTHER
SODIUM SULFACETAMIDE	SODIUM SULFACETAMIDE	liquid, topical	42192-129UNAPPROVED DRUG OTHER
SODIUM SULFACETAMIDE - SULFUR WASH	SODIUM SULFACETAMIDE, SULFUR	liquid, topical	42192-121UNAPPROVED DRUG OTHER
SODIUM SULFACETAMIDE and SULFUR Wash	SODIUM SULFACETAMIDE and SULFUR	liquid, topical	42192-104UNAPPROVED DRUG OTHER
SODIUM SULFACETAMIDE, SULFUR	Sodium Sulfacetamide and Sulfur	cream, topical	42192-139UNAPPROVED DRUG OTHER
SODIUM SULFACETAMIDE, SULFUR	Sodium Sulfacetamide and Sulfur	cream, topical	42192-149UNAPPROVED DRUG OTHER
Salicylic Acid	SALICYLIC ACID	gel, topical	42192-134UNAPPROVED DRUG OTHER
Sodium Sulfacetamide 10 Sulfur 2 Cleanser	Sulfacetamide Sodium and Sulfur	solution, topical	42192-147UNAPPROVED DRUG OTHER
Sodium Sulfacetamide 10 Sulfur 2 cream	Sulfacetamide Sodium and Sulfur	cream, topical	42192-150UNAPPROVED DRUG OTHER
Sodium Sulfacetamide 10 Sulfur 5 Cleanser	Sulfacetamide Sodium and Sulfur	rinse, topical	42192-136UNAPPROVED DRUG OTHER
Sodium Sulfacetamide 9 Sulfur 4.5 Wash	Sulfacetamide Sodium and Sulfur	rinse, topical	42192-144UNAPPROVED DRUG OTHER
Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser	SULFACETAMIDE SODIUM, SULFUR	liquid, topical	42192-156UNAPPROVED DRUG OTHER
Sodium Sulfacetamide and Sulfur	Sodium Sulfacetamide and Sulfur	solution, topical	42192-133UNAPPROVED DRUG OTHER
levonorgestrel and ethinyl estradiol	levonorgestrel and ethinyl estradiol	kit	42192-623NDA

Neighbours

Registered in the same town

Avion Pharmaceuticals, LLCAlpharetta, GA

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Enquiry

Common questions

Is Acella Pharmaceuticals, LLC FDA approved?: Acella Pharmaceuticals, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Acella Pharmaceuticals, LLC's drugs manufactured?: The FDA register lists Alpharetta, GA. Registered operations: finished drug manufacture, relabelling, repackaging.
What drugs does Acella Pharmaceuticals, LLC make?: 38 products are listed under Acella Pharmaceuticals, LLC in the openFDA NDC Directory, most often as tablet; liquid; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.