Package 53746-109-01
Brand: hydrocodone bitartrate and acetaminophen
Generic: hydrocodone bitartrate and acetaminophenPackage Facts
Identity
Package NDC
53746-109-01
Digits Only
5374610901
Product NDC
53746-109
Description
100 TABLET in 1 BOTTLE (53746-109-01)
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": "a83ec256-95c3-4b3a-b911-2eb415308a4d", "openfda": {"upc": ["0353746109101", "0353746109019"], "unii": ["362O9ITL9D", "NO70W886KK"], "rxcui": ["857002"], "spl_set_id": ["62be4147-6a72-49e5-9338-10887c65a93a"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-109-01)", "package_ndc": "53746-109-01", "marketing_start_date": "20100118"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-109-05)", "package_ndc": "53746-109-05", "marketing_start_date": "20100118"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-109-10)", "package_ndc": "53746-109-10", "marketing_start_date": "20100118"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "53746-109_a83ec256-95c3-4b3a-b911-2eb415308a4d", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "53746-109", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA040736", "marketing_category": "ANDA", "marketing_start_date": "20100118", "listing_expiration_date": "20261231"}