Doxylamine succinate and pyridoxine hydrochloride

Product NDC
63629-8358
11-digit product format
636298358
Labeler code
63629
Product ID
63629-8358_cc9ee8eb-9955-40f4-bf93-112cc233deed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxylamine succinate and pyridoxine hydrochloride
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021876
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-11-15
Marketing end
0000-00-00
Substance
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Active strength
10 mg/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8358-16362983580130 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-8358-1) 2020-12-170000-00-00NoNoCurrent