Package 0121-1018-30
Brand: buprenorphine and naloxone
Generic: buprenorphine hydrochloride and naloxone hydrochloridePackage Facts
Identity
Package NDC
0121-1018-30
Digits Only
0121101830
Product NDC
0121-1018
Description
30 TABLET in 1 BOTTLE, PLASTIC (0121-1018-30)
Marketing
Marketing Status
Brand
buprenorphine and naloxone
Generic
buprenorphine hydrochloride and naloxone hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["SUBLINGUAL"], "spl_id": "1ce649e8-2297-57de-e063-6394a90af242", "openfda": {"upc": ["0301211018304", "0301212036307"], "unii": ["56W8MW3EN1", "F850569PQR"], "rxcui": ["351266", "351267"], "spl_set_id": ["d5b011ef-f1be-47f2-8f8b-07553f36193c"], "manufacturer_name": ["PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (0121-1018-30)", "package_ndc": "0121-1018-30", "marketing_start_date": "20230905"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "0121-1018_1ce649e8-2297-57de-e063-6394a90af242", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0121-1018", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride and naloxone hydrochloride", "labeler_name": "PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA204431", "marketing_category": "ANDA", "marketing_start_date": "20230905", "listing_expiration_date": "20261231"}