Package 55494-100-10
Brand: diclegis
Generic: doxylamine succinate and pyridoxine hydrochloridePackage Facts
Identity
Package NDC
55494-100-10
Digits Only
5549410010
Product NDC
55494-100
Description
100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)
Marketing
Marketing Status
Brand
diclegis
Generic
doxylamine succinate and pyridoxine hydrochloride
Sample Package
No
Linked Drug Pages (1)
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"}