Package 0121-1008-12
Brand: acetaminophen and codeine phosphate
Generic: acetaminophen and codeine phosphatePackage Facts
Identity
Package NDC
0121-1008-12
Digits Only
0121100812
Product NDC
0121-1008
Description
12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)
Marketing
Marketing Status
Brand
acetaminophen and codeine phosphate
Generic
acetaminophen and codeine phosphate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "7cfdf5a3-ffd5-403b-8421-6275ca7cf02d", "openfda": {"upc": ["0301210504167", "0301210504044"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993755"], "spl_set_id": ["95ac6875-6b14-4cde-8efb-80704e39b8d8"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)", "package_ndc": "0121-1008-12", "marketing_start_date": "20241007"}, {"sample": false, "description": "40 TRAY in 1 CASE (0121-1008-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)", "package_ndc": "0121-1008-40", "marketing_start_date": "19810821"}], "brand_name": "Acetaminophen and Codeine Phosphate", "product_id": "0121-1008_7cfdf5a3-ffd5-403b-8421-6275ca7cf02d", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0121-1008", "dea_schedule": "CV", "generic_name": "ACETAMINOPHEN and CODEINE PHOSPHATE", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen and Codeine Phosphate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/12.5mL"}, {"name": "CODEINE PHOSPHATE", "strength": "30 mg/12.5mL"}], "application_number": "ANDA087508", "marketing_category": "ANDA", "marketing_start_date": "19810821", "listing_expiration_date": "20261231"}