Package 0054-0843-63
Brand: hydrocodone bitartrate and acetaminophen
Generic: hydrocodone bitartrate and acetaminophenPackage Facts
Identity
Package NDC
0054-0843-63
Digits Only
0054084363
Product NDC
0054-0843
Description
473 mL in 1 BOTTLE (0054-0843-63)
Marketing
Marketing Status
Brand
hydrocodone bitartrate and acetaminophen
Generic
hydrocodone bitartrate and acetaminophen
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "250056d2-c06c-76f1-e063-6394a90aec19", "openfda": {"unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["1044427"], "spl_set_id": ["995a6cc7-8b72-4d35-b3b4-8c5752438fb7"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0054-0843-63)", "package_ndc": "0054-0843-63", "marketing_start_date": "20250616"}], "brand_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "product_id": "0054-0843_250056d2-c06c-76f1-e063-6394a90aec19", "dosage_form": "LIQUID", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0054-0843", "dea_schedule": "CII", "generic_name": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/15mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/15mL"}], "application_number": "ANDA040881", "marketing_category": "ANDA", "marketing_start_date": "20250602", "listing_expiration_date": "20261231"}