Drug

Who makes doxylamine succinate and pyridoxine hydrochloride?

4 companies list doxylamine succinate and pyridoxine hydrochloride as a human prescription drug, including under the names BONJESTA, DICLEGIS. Forms: tablet, delayed release; tablet, extended release. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing doxylamine succinate and pyridoxine hydrochloride

CompanyFormsApplicationNDCsRegistered sites
Duchesnay Inc.Canadatablet, delayed release; tablet, extended releaseNDANDA021876, NDA20966121
Actavis LLCUnited Statestablet, delayed releaseANDAANDA20581111
Bionpharma Inc.Indiatablet, delayed releaseANDAANDA21700011
Analog Pharmatablet, delayed releaseNDA AUTHORIZED GENERICNDA02187610
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Common questions

Who makes doxylamine succinate and pyridoxine hydrochloride?
4 companies list doxylamine succinate and pyridoxine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Duchesnay Inc., Actavis LLC, Bionpharma Inc., Analog Pharma. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic BONJESTA?
2 companies list doxylamine succinate and pyridoxine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.