Package 47781-358-03
Brand: buprenorphine and naloxone sublingual film
Generic: buprenorphine and naloxonePackage Facts
Identity
Package NDC
47781-358-03
Digits Only
4778135803
Product NDC
47781-358
Description
30 POUCH in 1 CARTON (47781-358-03) / 1 FILM in 1 POUCH (47781-358-11)
Marketing
Marketing Status
Brand
buprenorphine and naloxone sublingual film
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": "afb884aa-0110-dd76-ba93-6dfcbe806f97", "openfda": {"upc": ["0347781356118", "0347781358037", "0347781355036", "0347781357030", "0347781356033", "0347781358112", "0347781357115", "0347781355111"], "unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["1010600", "1010604", "1307056", "1307061"], "spl_set_id": ["4210afeb-474c-d842-d68e-af7e0021851a"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (47781-358-03) / 1 FILM in 1 POUCH (47781-358-11)", "package_ndc": "47781-358-03", "marketing_start_date": "20190211"}], "brand_name": "Buprenorphine and Naloxone Sublingual Film", "product_id": "47781-358_afb884aa-0110-dd76-ba93-6dfcbe806f97", "dosage_form": "FILM", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "47781-358", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Alvogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "brand_name_suffix": "Sublingual Film", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "12 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "3 mg/1"}], "application_number": "ANDA205954", "marketing_category": "ANDA", "marketing_start_date": "20190211", "listing_expiration_date": "20261231"}