Package 76420-534-30

Brand: buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydrate
NDC Package

Package 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
Marketed Since 2023-01-27
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"}