NDC 70505-100

Doxylamine succinate and pyridoxine hydrochloride

Doxylamine Succinate And Pyridoxine Hydrochloride

Doxylamine succinate and pyridoxine hydrochloride is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Analog Pharma. The primary component is Doxylamine Succinate; Pyridoxine Hydrochloride.

Product ID70505-100_13226ffe-3b1a-4153-b28c-4f374916c443
NDC70505-100
Product TypeHuman Prescription Drug
Proprietary NameDoxylamine succinate and pyridoxine hydrochloride
Generic NameDoxylamine Succinate And Pyridoxine Hydrochloride
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-11-15
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021876
Labeler NameAnalog Pharma
Substance NameDOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesAntihistamine [EPC],Histamine Receptor Antagonists [MoA],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70505-100-10

100 TABLET, DELAYED RELEASE in 1 BOTTLE (70505-100-10)
Marketing Start Date2018-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70505-100-10 [70505010010]

Doxylamine succinate and pyridoxine hydrochloride TABLET, DELAYED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA021876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-15

Drug Details

Active Ingredients

IngredientStrength
DOXYLAMINE SUCCINATE10 mg/1

OpenFDA Data

SPL SET ID:76d10d65-0279-4e86-8104-cade4343f839
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1375948

    • Pharmacological Class

    • Antihistamine [EPC]
    • Histamine Receptor Antagonists [MoA]
    • Vitamin B6 Analog [EPC]
    • Vitamin B 6 [Chemical/Ingredient]
    • Analogs/Derivatives [Chemical/Ingredient]

    NDC Crossover Matching brand name "Doxylamine succinate and pyridoxine hydrochloride" or generic name "Doxylamine Succinate And Pyridoxine Hydrochloride"

    NDCBrand NameGeneric Name
    0378-4615Doxylamine Succinate and Pyridoxine Hydrochloridedoxylamine succinate and pyridoxine hydrochloride
    0591-2132Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochloride
    49884-186Doxylamine Succinate and Pyridoxine HydrochlorideDoxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg
    63629-2184Doxylamine Succinate and Pyridoxine HydrochlorideDoxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg
    63629-8358Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochloride
    70505-100Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochloride
    55494-120BONJESTAdoxylamine succinate and pyridoxine hydrochloride
    55494-100DICLEGISdoxylamine succinate and pyridoxine hydrochloride
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