Package 58118-8005-8

Brand: buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydrate
NDC Package

Package 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
Marketed Since 2023-07-11
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"}