Package 65162-416-09
Brand: buprenorphine hcl and naloxone hcl
Generic: buprenorphine and naloxonePackage Facts
Identity
Package NDC
65162-416-09
Digits Only
6516241609
Product NDC
65162-416
Description
90 TABLET in 1 BOTTLE (65162-416-09)
Marketing
Marketing Status
Brand
buprenorphine hcl and naloxone hcl
Generic
buprenorphine and naloxone
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["SUBLINGUAL"], "spl_id": "4cea862f-8edf-4035-a7f5-328beff51a29", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["17b63f10-c9df-44be-80fa-6f1c305583b8"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-416-03)", "package_ndc": "65162-416-03", "marketing_start_date": "20130222"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-416-09)", "package_ndc": "65162-416-09", "marketing_start_date": "20130222"}], "brand_name": "Buprenorphine HCl and Naloxone HCl", "product_id": "65162-416_4cea862f-8edf-4035-a7f5-328beff51a29", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "65162-416", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine HCl and Naloxone HCl", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": ".5 mg/1"}], "application_number": "ANDA203136", "marketing_category": "ANDA", "marketing_start_date": "20130222", "listing_expiration_date": "20271231"}