Package 13107-109-05
Brand: hydromorphone hydrochloride
Generic: hydromorphone hydrochloridePackage Facts
Identity
Package NDC
13107-109-05
Digits Only
1310710905
Product NDC
13107-109
Description
500 TABLET in 1 BOTTLE (13107-109-05)
Marketing
Marketing Status
Brand
hydromorphone hydrochloride
Generic
hydromorphone hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "1c45740c-5fb6-4cf7-81b9-0865717334e5", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["897696", "897702", "897710"], "spl_set_id": ["f778dfab-e109-428e-b1b7-4dfb1b8293e4"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-109-01)", "package_ndc": "13107-109-01", "marketing_start_date": "20160517"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13107-109-05)", "package_ndc": "13107-109-05", "marketing_start_date": "20160517"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (13107-109-20)", "package_ndc": "13107-109-20", "marketing_start_date": "20160517"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-109-99)", "package_ndc": "13107-109-99", "marketing_start_date": "20160517"}], "brand_name": "HYDROMORPHONE HYDROCHLORIDE", "product_id": "13107-109_1c45740c-5fb6-4cf7-81b9-0865717334e5", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13107-109", "dea_schedule": "CII", "generic_name": "HYDROMORPHONE HYDROCHLORIDE", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROMORPHONE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA205814", "marketing_category": "ANDA", "marketing_start_date": "20160517", "listing_expiration_date": "20261231"}