Is Gendose Pharmaceuticals, LLC FDA approved?

Gendose Pharmaceuticals, LLC holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Gendose Pharmaceuticals, LLC make?

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

Gendose Pharmaceuticals, LLC

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

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Registered sites: 0
Active NDC listings: 11
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

11 active NDC listings: 11 human otc drug. By marketing category: OTC MONOGRAPH DRUG 11.

Dosage form	NDCs
tablet	4
capsule	2
tablet, chewable	2
tablet, delayed release	2
tablet, film coated	1

Route	NDCs
oral	11

Labeller name on the listing	NDCs
gendose pharmaceuticals, llc	11

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Antihistamine	Diphenhydramine HCl	capsule, oral	77333-227OTC MONOGRAPH DRUG
Antihistamine	Diphenhydramine HCl	capsule, oral	77333-231OTC MONOGRAPH DRUG
Aspirin	Aspirin	tablet, film coated, oral	77333-050OTC MONOGRAPH DRUG
Aspirin 81mg	Aspirin	tablet, chewable, oral	77333-049OTC MONOGRAPH DRUG
Aspirin 81mg Enteric Coated	Aspirin	tablet, delayed release, oral	77333-031OTC MONOGRAPH DRUG
Aspirin Enteric Coated, Regular Strength	Aspirin	tablet, delayed release, oral	77333-035OTC MONOGRAPH DRUG
FIBER LAXATIVE CAPLETS	CALCIUM POLYCARBOPHIL	tablet, oral	77333-120OTC MONOGRAPH DRUG
GUAIFENESIN 400MG CAPLETS	GUAIFENESIN	tablet, oral	77333-360OTC MONOGRAPH DRUG
SIMETHICONE 80MG	SIMETHICONE	tablet, chewable, oral	77333-812OTC MONOGRAPH DRUG
SODIUM CHLORIDE 1 GRAM	SODIUM CHLORIDE	tablet, oral	77333-846OTC MONOGRAPH DRUG
Sodium Bicarbonate 10 gr. (650 mg)	Sodium Bicarbonate	tablet, oral	77333-829OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Gendose Pharmaceuticals, LLC FDA approved?: Gendose Pharmaceuticals, LLC holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Gendose Pharmaceuticals, LLC make?: 11 products are listed under Gendose Pharmaceuticals, LLC in the openFDA NDC Directory, most often as tablet; capsule; tablet, chewable. 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.