NDC 55494-100

DICLEGIS

Doxylamine Succinate And Pyridoxine Hydrochloride

DICLEGIS is a Oral Tablet, Delayed 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: 55494-100_10a9c633-2d2c-48f3-ab9c-655716ea4278
• NDC: 55494-100
• Product Type: Human Prescription Drug
• Proprietary Name: DICLEGIS
• Generic Name: Doxylamine Succinate And Pyridoxine Hydrochloride
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-05-15
• Marketing Category: NDA / NDA
• Application Number: NDA021876
• Labeler Name: Duchesnay USA, Inc.
• Substance Name: DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1; mg/1
• Pharm Classes: Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 55494-100-10

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

• Marketing Start Date: 2013-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55494-100-99 [55494010099]

DICLEGIS TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA021876
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-03-28

NDC 55494-100-10 [55494010010]

DICLEGIS TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA021876
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-05-15

Drug Details

Active Ingredients

Ingredient	Strength
DOXYLAMINE SUCCINATE	10 mg/1

OpenFDA Data

• SPL SET ID: 8bde08f6-e8bd-4e90-baa7-82e01876a86a
• Manufacturer:
  • Duchesnay USA, Inc.
• UNII:
  • V9BI9B5YI2
  • 68Y4CF58BV
• RxNorm Concept Unique ID - RxCUI:
  • 1375954
  • 1375948

Pharmacological Class

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

Medicade Reported Pricing

55494010010 DICLEGIS DR 10-10 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
55494-100	DICLEGIS	doxylamine succinate and pyridoxine hydrochloride
55494-120	BONJESTA	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