Package 0378-8766-93
Brand: buprenorphine and naloxone
Generic: buprenorphine and naloxonePackage Facts
Identity
Package NDC
0378-8766-93
Digits Only
0378876693
Product NDC
0378-8766
Description
30 POUCH in 1 CARTON (0378-8766-93) / 1 FILM in 1 POUCH (0378-8766-16)
Marketing
Marketing Status
Brand
buprenorphine and naloxone
Generic
buprenorphine and naloxone
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["BUCCAL", "SUBLINGUAL"], "spl_id": "008d89ec-5bd7-46d9-bc94-9cdc7405f95d", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["1010600", "1010604", "1307056", "1307061"], "spl_set_id": ["557d8d4d-8751-431c-b18e-9d5cf23fc579"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0378-8766-93) / 1 FILM in 1 POUCH (0378-8766-16)", "package_ndc": "0378-8766-93", "marketing_start_date": "20200417"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "0378-8766_008d89ec-5bd7-46d9-bc94-9cdc7405f95d", "dosage_form": "FILM", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0378-8766", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "4 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "1 mg/1"}], "application_number": "ANDA211785", "marketing_category": "ANDA", "marketing_start_date": "20200417", "listing_expiration_date": "20271231"}