Package 0713-0823-75
Brand: promethazine hydrochloride and codeine phosphate
Generic: promethazine hydrochloride and codeine phosphatePackage 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
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"}