Package 0378-4615-01

Brand: doxylamine succinate and pyridoxine hydrochloride

Generic: doxylamine succinate and pyridoxine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 0378-4615-01
Digits Only 0378461501
Product NDC 0378-4615
Description

100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01)

Marketing

Marketing Status
Discontinued 2026-05-31
Brand doxylamine succinate and pyridoxine hydrochloride
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": "948c17d8-e019-4e4e-b93b-a775ec327a6d", "openfda": {"upc": ["0303784615010"], "unii": ["V9BI9B5YI2", "68Y4CF58BV"], "rxcui": ["1375948"], "spl_set_id": ["957865a2-efcf-43a6-92a8-f9f980892833"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01)", "package_ndc": "0378-4615-01", "marketing_end_date": "20260531", "marketing_start_date": "20200721"}], "brand_name": "Doxylamine Succinate and Pyridoxine Hydrochloride", "product_id": "0378-4615_948c17d8-e019-4e4e-b93b-a775ec327a6d", "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": "0378-4615", "generic_name": "doxylamine succinate and pyridoxine hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxylamine Succinate and Pyridoxine Hydrochloride", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "10 mg/1"}, {"name": "PYRIDOXINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA207825", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20200721"}