buprenorphine and naloxone

Generic: buprenorphine and naloxone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone
Generic Name buprenorphine and naloxone
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine 8 mg/1, naloxone 2 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1378
Product ID 71335-1378_154fc76d-ff38-473b-aaa5-017237455b85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205022
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2016-09-19

Pharmacologic Class

Established (EPC)
partial opioid agonist [epc] opioid antagonist [epc]
Mechanism of Action
partial opioid agonists [moa] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713351378
Hyphenated Format 71335-1378

Supplemental Identifiers

RxCUI
351267
UNII
40D3SCR4GZ 36B82AMQ7N
NUI
N0000175689 N0000175685 N0000175691 N0000000154

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name buprenorphine and naloxone (source: ndc)
Generic Name buprenorphine and naloxone (source: ndc)
Application Number ANDA205022 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 42 TABLET in 1 BOTTLE (71335-1378-0)
  • 30 TABLET in 1 BOTTLE (71335-1378-1)
  • 60 TABLET in 1 BOTTLE (71335-1378-2)
  • 90 TABLET in 1 BOTTLE (71335-1378-3)
  • 120 TABLET in 1 BOTTLE (71335-1378-4)
  • 14 TABLET in 1 BOTTLE (71335-1378-5)
  • 28 TABLET in 1 BOTTLE (71335-1378-6)
  • 6 TABLET in 1 BOTTLE (71335-1378-7)
  • 10 TABLET in 1 BOTTLE (71335-1378-8)
  • 21 TABLET in 1 BOTTLE (71335-1378-9)
source: ndc

Packages (10)

71335-1378-0 42 TABLET in 1 BOTTLE (71335-1378-0) 71335-1378-1 30 TABLET in 1 BOTTLE (71335-1378-1) 71335-1378-2 60 TABLET in 1 BOTTLE (71335-1378-2) 71335-1378-3 90 TABLET in 1 BOTTLE (71335-1378-3) 71335-1378-4 120 TABLET in 1 BOTTLE (71335-1378-4) 71335-1378-5 14 TABLET in 1 BOTTLE (71335-1378-5) 71335-1378-6 28 TABLET in 1 BOTTLE (71335-1378-6) 71335-1378-7 6 TABLET in 1 BOTTLE (71335-1378-7) 71335-1378-8 10 TABLET in 1 BOTTLE (71335-1378-8) 71335-1378-9 21 TABLET in 1 BOTTLE (71335-1378-9)

Ingredients (2)

buprenorphine (8 mg/1) naloxone (2 mg/1)

Linked Drug Pages (1)

Buprenorphine and Naloxone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "154fc76d-ff38-473b-aaa5-017237455b85", "openfda": {"nui": ["N0000175689", "N0000175685", "N0000175691", "N0000000154"], "unii": ["40D3SCR4GZ", "36B82AMQ7N"], "rxcui": ["351267"], "spl_set_id": ["2063d5bf-b3bc-4e73-9046-7e994446ab50"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]", "Opioid Antagonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]", "Opioid Antagonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "42 TABLET in 1 BOTTLE (71335-1378-0)", "package_ndc": "71335-1378-0", "marketing_start_date": "20240520"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1378-1)", "package_ndc": "71335-1378-1", "marketing_start_date": "20191025"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1378-2)", "package_ndc": "71335-1378-2", "marketing_start_date": "20240520"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1378-3)", "package_ndc": "71335-1378-3", "marketing_start_date": "20240520"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71335-1378-4)", "package_ndc": "71335-1378-4", "marketing_start_date": "20240520"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (71335-1378-5)", "package_ndc": "71335-1378-5", "marketing_start_date": "20240520"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71335-1378-6)", "package_ndc": "71335-1378-6", "marketing_start_date": "20240520"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (71335-1378-7)", "package_ndc": "71335-1378-7", "marketing_start_date": "20240520"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (71335-1378-8)", "package_ndc": "71335-1378-8", "marketing_start_date": "20240520"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (71335-1378-9)", "package_ndc": "71335-1378-9", "marketing_start_date": "20240520"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "71335-1378_154fc76d-ff38-473b-aaa5-017237455b85", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "71335-1378", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE", "strength": "8 mg/1"}, {"name": "NALOXONE", "strength": "2 mg/1"}], "application_number": "ANDA205022", "marketing_category": "ANDA", "marketing_start_date": "20160919", "listing_expiration_date": "20261231"}