NDC 0591-2132

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 Actavis Pharma, Inc.. The primary component is Doxylamine Succinate; Pyridoxine Hydrochloride.

• Product ID: 0591-2132_3dd1b394-c75c-4bb1-9016-56f75d764e7e
• NDC: 0591-2132
• Product Type: Human Prescription Drug
• Proprietary Name: Doxylamine succinate and pyridoxine hydrochloride
• Generic Name: Doxylamine Succinate And Pyridoxine Hydrochloride
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205811
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1; mg/1
• Pharm Classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0591-2132-01

100 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2132-01)

• Marketing Start Date: 2019-06-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-2132-01 [00591213201]

Doxylamine succinate and pyridoxine hydrochloride TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA205811
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-21

Drug Details

Active Ingredients

Ingredient	Strength
DOXYLAMINE SUCCINATE	10 mg/1

OpenFDA Data

• SPL SET ID: 3670d66e-c1e4-42ce-8760-c3d5accad925
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • V9BI9B5YI2
  • 68Y4CF58BV
• 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]
• 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"

NDC	Brand Name	Generic Name
0378-4615	Doxylamine Succinate and Pyridoxine Hydrochloride	doxylamine succinate and pyridoxine hydrochloride
0591-2132	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride
49884-186	Doxylamine Succinate and Pyridoxine Hydrochloride	Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg
63629-2184	Doxylamine Succinate and Pyridoxine Hydrochloride	Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg
63629-8358	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride
70505-100	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride
55494-120	BONJESTA	doxylamine succinate and pyridoxine hydrochloride
55494-100	DICLEGIS	doxylamine succinate and pyridoxine hydrochloride