doxylamine succinate and pyridoxine hydrochloride
doxylamine succinate and pyridoxine hydrochloride is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including BONJESTA, DICLEGIS. Available dosage forms: tablet, extended release, tablet, delayed release.
Drug Details
- Generic Name
- doxylamine succinate and pyridoxine hydrochloride
- Brand Names
- BONJESTA, DICLEGIS
- Application Number
- NDA209661
- Sponsor
- Duchesnay USA, Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use BONJESTA has not been studied in women with hyperemesis gravidarum. BONJESTA is a fixed dose combination drug product of 20 mg doxylamine succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a Vitamin B 6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. ( 1 )