Doxylamine Succinate and Pyridoxine Hydrochloride

Product NDC
72162-1485
11-digit product format
721621485
Labeler code
72162
Product ID
72162-1485_cc985325-f831-4f1a-8111-2ce9fce02a96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208518
Marketing category
ANDA
Marketing start
2019-12-19
Substance
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Active strength
10; 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
V9BI9B5YI2DOXYLAMINE SUCCINATE562-10-7DOXYLAMINE SUCCINATE
68Y4CF58BVPYRIDOXINE HYDROCHLORIDE58-56-0PYRIDOXINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1485-172162148501100 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-1485-1) 2023-08-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Doxylamine Succinate and Pyridoxine HydrochlorideBryant Ranch Prepack2023-08-30HUMAN PRESCRIPTION DRUG LABEL100