diclegis

Generic: doxylamine succinate and pyridoxine hydrochloride

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

Drug Facts

Product Profile

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

doxylamine succinate 10 mg/1, pyridoxine hydrochloride 10 mg/1

Manufacturer
Duchesnay USA, Inc.

Identifiers & Regulatory

Product NDC 55494-100
Product ID 55494-100_19a108be-4aba-4906-8a5d-35f5b263b1c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021876
Listing Expiration 2026-12-31
Marketing Start 2013-05-15

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 55494100
Hyphenated Format 55494-100

Supplemental Identifiers

RxCUI
1375948 1375954
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 diclegis (source: ndc)
Generic Name doxylamine succinate and pyridoxine hydrochloride (source: ndc)
Application Number NDA021876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)
  • 12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)
source: ndc

Packages (2)

55494-100-10 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) 55494-100-99 12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)

Ingredients (2)

doxylamine succinate (10 mg/1) pyridoxine hydrochloride (10 mg/1)

Linked Drug Pages (1)

DICLEGIS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "19a108be-4aba-4906-8a5d-35f5b263b1c2", "openfda": {"unii": ["V9BI9B5YI2", "68Y4CF58BV"], "rxcui": ["1375948", "1375954"], "spl_set_id": ["8bde08f6-e8bd-4e90-baa7-82e01876a86a"], "manufacturer_name": ["Duchesnay USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)", "package_ndc": "55494-100-10", "marketing_start_date": "20130515"}, {"sample": true, "description": "12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)", "package_ndc": "55494-100-99", "marketing_start_date": "20140328"}], "brand_name": "DICLEGIS", "product_id": "55494-100_19a108be-4aba-4906-8a5d-35f5b263b1c2", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Analogs/Derivatives [Chemical/Ingredient]", "Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Vitamin B 6 [Chemical/Ingredient]", "Vitamin B6 Analog [EPC]"], "product_ndc": "55494-100", "generic_name": "doxylamine succinate and pyridoxine hydrochloride", "labeler_name": "Duchesnay USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICLEGIS", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "10 mg/1"}, {"name": "PYRIDOXINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA021876", "marketing_category": "NDA", "marketing_start_date": "20130515", "listing_expiration_date": "20261231"}