NDC 55494-120

BONJESTA

Doxylamine Succinate And Pyridoxine Hydrochloride

BONJESTA is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Duchesnay Usa, Inc.. The primary component is Doxylamine Succinate; Pyridoxine Hydrochloride.

• Product ID: 55494-120_19dc35cc-1438-418f-b3bc-a74904199110
• NDC: 55494-120
• Product Type: Human Prescription Drug
• Proprietary Name: BONJESTA
• Generic Name: Doxylamine Succinate And Pyridoxine Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2018-02-19
• Marketing Category: NDA / NDA
• Application Number: NDA209661
• Labeler Name: Duchesnay USA, Inc.
• Substance Name: DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
• Active Ingredient Strength: 20 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: 2022-12-31

Packaging

NDC 55494-120-10

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)

• Marketing Start Date: 2018-02-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55494-120-99 [55494012099]

BONJESTA TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA209661
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-02-19

NDC 55494-120-60 [55494012060]

BONJESTA TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA209661
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-02-19

NDC 55494-120-10 [55494012010]

BONJESTA TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA209661
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-02-19

Drug Details

Active Ingredients

Ingredient	Strength
DOXYLAMINE SUCCINATE	20 mg/1

OpenFDA Data

• SPL SET ID: dba60bb4-54ff-4e06-b8d2-acbbd3717666
• Manufacturer:
  • Duchesnay USA, Inc.
• UNII:
  • V9BI9B5YI2
  • 68Y4CF58BV
• RxNorm Concept Unique ID - RxCUI:
  • 1999657
  • 1999651
• UPC Code:
  • 0355494120605

Pharmacological Class

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

Medicade Reported Pricing

55494012060 BONJESTA ER 20-20 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "BONJESTA" or generic name "Doxylamine Succinate And Pyridoxine Hydrochloride"

NDC	Brand Name	Generic Name
55494-120	BONJESTA	doxylamine succinate and pyridoxine hydrochloride
55494-100	DICLEGIS	doxylamine succinate and pyridoxine hydrochloride
0378-4615	Doxylamine Succinate and Pyridoxine Hydrochloride	doxylamine succinate and pyridoxine hydrochloride
0591-2132	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride
63629-8358	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride
70505-100	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride