Package 71335-1653-1
Brand: buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydratePackage Facts
Identity
Package NDC
71335-1653-1
Digits Only
7133516531
Product NDC
71335-1653
Description
30 TABLET in 1 BOTTLE (71335-1653-1)
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": "9a39f42e-fe24-407d-b21c-49fafb0040a4", "openfda": {"unii": ["56W8MW3EN1", "5Q187997EE"], "rxcui": ["351266"], "spl_set_id": ["d25b1a73-9794-4e86-82eb-dee3f159a214"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1653-1)", "package_ndc": "71335-1653-1", "marketing_start_date": "20201029"}], "brand_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "product_id": "71335-1653_9a39f42e-fe24-407d-b21c-49fafb0040a4", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "71335-1653", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "buprenorphine hydrochloride and naloxone hydrochloride dihydrate", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": ".5 mg/1"}], "application_number": "ANDA203326", "marketing_category": "ANDA", "marketing_start_date": "20140627", "listing_expiration_date": "20261231"}