bonjesta

Generic: doxylamine succinate and pyridoxine hydrochloride

Labeler: duchesnay usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bonjesta
Generic Name doxylamine succinate and pyridoxine hydrochloride
Labeler duchesnay usa, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

doxylamine succinate 20 mg/1, pyridoxine hydrochloride 20 mg/1

Manufacturer
Duchesnay USA, Inc.

Identifiers & Regulatory

Product NDC 55494-120
Product ID 55494-120_3e4fbcb3-ac64-4673-b46f-a2ce616d4374
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209661
Listing Expiration 2026-12-31
Marketing Start 2018-02-19

Pharmacologic Class

Classes
analogs/derivatives [chemical/ingredient] antihistamine [epc] histamine receptor antagonists [moa] vitamin b 6 [chemical/ingredient] vitamin b6 analog [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55494120
Hyphenated Format 55494-120

Supplemental Identifiers

RxCUI
1999651 1999657
UPC
0355494120605
UNII
V9BI9B5YI2 68Y4CF58BV

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bonjesta (source: ndc)
Generic Name doxylamine succinate and pyridoxine hydrochloride (source: ndc)
Application Number NDA209661 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60)
  • 1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99)
source: ndc

Packages (4)

55494-120-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10) 55494-120-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60) 55494-120-94 1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 55494-120-99 6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99)

Ingredients (2)

doxylamine succinate (20 mg/1) pyridoxine hydrochloride (20 mg/1)

Linked Drug Pages (1)

BONJESTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e4fbcb3-ac64-4673-b46f-a2ce616d4374", "openfda": {"upc": ["0355494120605"], "unii": ["V9BI9B5YI2", "68Y4CF58BV"], "rxcui": ["1999651", "1999657"], "spl_set_id": ["dba60bb4-54ff-4e06-b8d2-acbbd3717666"], "manufacturer_name": ["Duchesnay USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)", "package_ndc": "55494-120-10", "marketing_start_date": "20180219"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60)", "package_ndc": "55494-120-60", "marketing_start_date": "20180219"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (55494-120-94)  / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "55494-120-94", "marketing_start_date": "20250226"}, {"sample": true, "description": "6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99)", "package_ndc": "55494-120-99", "marketing_start_date": "20180219"}], "brand_name": "BONJESTA", "product_id": "55494-120_3e4fbcb3-ac64-4673-b46f-a2ce616d4374", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Analogs/Derivatives [Chemical/Ingredient]", "Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Vitamin B 6 [Chemical/Ingredient]", "Vitamin B6 Analog [EPC]"], "product_ndc": "55494-120", "generic_name": "doxylamine succinate and pyridoxine hydrochloride", "labeler_name": "Duchesnay USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BONJESTA", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "20 mg/1"}, {"name": "PYRIDOXINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "NDA209661", "marketing_category": "NDA", "marketing_start_date": "20180219", "listing_expiration_date": "20261231"}