Package 76420-534-30
Brand: buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydratePackage Facts
Identity
Package NDC
76420-534-30
Digits Only
7642053430
Product NDC
76420-534
Description
30 TABLET in 1 BOTTLE, PLASTIC (76420-534-30)
Marketing
Marketing Status
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": "f33905ee-0218-1314-e053-2a95a90a25c7", "openfda": {"unii": ["56W8MW3EN1", "5Q187997EE"], "rxcui": ["351267"], "spl_set_id": ["597cbc69-84b1-4255-bed9-53d0c6dc2134"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (76420-534-30)", "package_ndc": "76420-534-30", "marketing_start_date": "20230127"}], "brand_name": "BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE", "product_id": "76420-534_f33905ee-0218-1314-e053-2a95a90a25c7", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "76420-534", "dea_schedule": "CIII", "generic_name": "BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "2 mg/1"}], "application_number": "ANDA209069", "marketing_category": "ANDA", "marketing_start_date": "20210122", "listing_expiration_date": "20261231"}