Is Seton Pharmaceuticals, LLC FDA approved?

Seton Pharmaceuticals, LLC holds no registered establishment of its own; 14 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Seton Pharmaceuticals, LLC make?

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

Seton Pharmaceuticals, LLC

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

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Registered sites: 0
Active NDC listings: 14
Labeller names: 3
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

14 active NDC listings: 14 human prescription drug. By marketing category: UNAPPROVED DRUG OTHER 8, ANDA 5, NDA 1.

Dosage form	NDCs
cream	4
capsule	2
solution	2
capsule, gelatin coated	1
gel	1
inhalant	1
injection, powder, lyophilized, for solution	1
tablet	1
tablet, chewable	1

Route	NDCs
oral	7
rectal	3
topical	2
intramuscular	1
intravenous	1
respiratory (inhalation)	1

Labeller name on the listing	NDCs
seton pharmaceuticals	11
seton pharmaceuticals llc	2
seton pharmaceuticals, llc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	butalbital, acetaminophen and caffeine	capsule, oral	13925-535ANDA
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	butalbital, acetaminophen and caffeine	capsule, oral	13925-536ANDA
Lidocaine Hydrochloride	Lidocaine Hydrochloride	cream, topical	13925-159UNAPPROVED DRUG OTHER
Lidocaine Hydrochloride and Hydrocortisone Acetate	Lidocaine Hydrochloride and Hydrocortisone Acetate	cream, topical	13925-160UNAPPROVED DRUG OTHER
Lidocaine Hydrochloride and Hydrocortisone Acetate	Lidocaine Hydrochloride and Hydrocortisone Acetate	cream, rectal	13925-163UNAPPROVED DRUG OTHER
Lidocaine Hydrochloride and Hydrocortisone Acetate	Lidocaine Hydrochloride and Hydrocortisone Acetate	gel, rectal	13925-164UNAPPROVED DRUG OTHER
Lidocaine Hydrochloride and Hydrocortisone Acetate	Lidocaine Hydrochloride and Hydrocortisone Acetate	cream, rectal	13925-165UNAPPROVED DRUG OTHER
Memantine Hydrochloride	Memantine Hydrochloride Oral	solution, oral	13925-540ANDA
Pentamidine Isethionate	Pentamidine Isethionate	injection, powder, lyophilized, for solution, intramuscular, intravenous	13925-515ANDA
Pentamidine Isethionate	Pentamidine Isethionate	inhalant, respiratory (inhalation)	13925-522ANDA
Prednisolone Sodium Phosphate	Prednisolone Sodium Phosphate	solution, oral	13925-166NDA
Se-Natal 19	.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium	tablet, oral	13925-116UNAPPROVED DRUG OTHER
Se-Natal 19 Chewable	Vitamins and Minerals	tablet, chewable, oral	13925-117UNAPPROVED DRUG OTHER
Se-Tan PLUS	MULTIVITAMIN/MINERAL	capsule, gelatin coated, oral	13925-118UNAPPROVED DRUG OTHER

Compare

Other companies listing lidocaine hydrochloride and hydrocortisone acetate

Westminster Pharmaceuticals, LLC0 sites · 181 NDC

Enquiry

Common questions

Is Seton Pharmaceuticals, LLC FDA approved?: Seton Pharmaceuticals, LLC holds no registered establishment of its own; 14 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Seton Pharmaceuticals, LLC make?: 14 products are listed under Seton Pharmaceuticals, LLC in the openFDA NDC Directory, most often as cream; capsule; 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.