Package 58118-8005-8
Brand: buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydratePackage Facts
Identity
Package NDC
58118-8005-8
Digits Only
5811880058
Product NDC
58118-8005
Description
30 TABLET in 1 BLISTER PACK (58118-8005-8)
Marketing
Marketing Status
Brand
buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Generic
buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["SUBLINGUAL"], "spl_id": "0e89609b-bd43-291f-e063-6294a90a623e", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["273b79ac-2c62-4407-9cd1-2a2964ef13ba"], "manufacturer_name": ["Clinical Solutions Wholesale, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (58118-8005-8)", "package_ndc": "58118-8005-8", "marketing_start_date": "20230711"}], "brand_name": "Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate", "product_id": "58118-8005_0e89609b-bd43-291f-e063-6294a90a623e", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "58118-8005", "dea_schedule": "CIII", "generic_name": "Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate", "labeler_name": "Clinical Solutions Wholesale, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": ".5 mg/1"}], "application_number": "ANDA207000", "marketing_category": "ANDA", "marketing_start_date": "20171213", "listing_expiration_date": "20261231"}