Package 0713-0823-75

Brand: promethazine hydrochloride and codeine phosphate

Generic: promethazine hydrochloride and codeine phosphate
NDC Package

Package Facts

Identity

Package NDC 0713-0823-75
Digits Only 0713082375
Product NDC 0713-0823
Description

473 mL in 1 BOTTLE, PLASTIC (0713-0823-75)

Marketing

Marketing Status
Marketed Since 2025-12-19
Brand promethazine hydrochloride and codeine phosphate
Generic promethazine hydrochloride and codeine phosphate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "ad6f539c-d968-4a3b-9550-ab7e78bee74c", "openfda": {"upc": ["0307130823753"], "unii": ["GSL05Y1MN6", "R61ZEH7I1I"], "rxcui": ["991486"], "spl_set_id": ["3b02cda4-9b24-79c9-e063-6294a90af5b9"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0713-0823-75)", "package_ndc": "0713-0823-75", "marketing_start_date": "20251219"}], "brand_name": "Promethazine Hydrochloride and Codeine Phosphate", "product_id": "0713-0823_ad6f539c-d968-4a3b-9550-ab7e78bee74c", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]", "Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0713-0823", "dea_schedule": "CV", "generic_name": "Promethazine Hydrochloride and Codeine Phosphate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Codeine Phosphate", "active_ingredients": [{"name": "CODEINE PHOSPHATE", "strength": "10 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA200386", "marketing_category": "ANDA", "marketing_start_date": "20251219", "listing_expiration_date": "20261231"}