Package 50991-540-20

Brand: duratuss ac

Generic: codeine phosphate, dexbrompheniramine maleate
NDC Package

Package Facts

Identity

Package NDC 50991-540-20
Digits Only 5099154020
Product NDC 50991-540
Product ID 50991-540_3e5ed178-d5d8-b8d4-e063-6394a90a91db
Description

20 mL in 1 BOTTLE (50991-540-20)

Marketing

Marketing Status
Marketed Since 2025-09-08
Brand duratuss ac
Generic codeine phosphate, dexbrompheniramine maleate
Sample Package No

Linked Drug Pages (1)

Duratuss AC ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e5ed178-d5d8-b8d4-e063-6394a90a91db", "openfda": {"unii": ["GSL05Y1MN6", "BPA9UT29BS"], "rxcui": ["2727418"], "spl_set_id": ["3e5ed178-d5d9-b8d4-e063-6394a90a91db"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (50991-540-16)", "package_ndc": "50991-540-16", "marketing_start_date": "20250908"}, {"sample": false, "description": "20 mL in 1 BOTTLE (50991-540-20)", "package_ndc": "50991-540-20", "marketing_start_date": "20250908"}], "brand_name": "Duratuss AC", "product_id": "50991-540_3e5ed178-d5d8-b8d4-e063-6394a90a91db", "dosage_form": "LIQUID", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "50991-540", "dea_schedule": "CV", "generic_name": "Codeine Phosphate, Dexbrompheniramine Maleate", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Duratuss AC", "active_ingredients": [{"name": "CODEINE PHOSPHATE", "strength": "10 mg/5mL"}, {"name": "DEXBROMPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250908", "listing_expiration_date": "20261231"}