buprenorphine hcl

Generic: buprenorphine hcl

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

Drug Facts

Product Profile

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

buprenorphine hydrochloride 8 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1163
Product ID 71335-1163_4ee49cc8-55ca-4274-9ea6-70d7891d8853
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078633
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2009-10-08

Pharmacologic Class

Classes
partial opioid agonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713351163
Hyphenated Format 71335-1163

Supplemental Identifiers

RxCUI
351265
UNII
56W8MW3EN1

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 hcl (source: ndc)
Generic Name buprenorphine hcl (source: ndc)
Application Number ANDA078633 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (71335-1163-0)
  • 90 TABLET in 1 BOTTLE (71335-1163-1)
  • 60 TABLET in 1 BOTTLE (71335-1163-2)
  • 30 TABLET in 1 BOTTLE (71335-1163-3)
  • 20 TABLET in 1 BOTTLE (71335-1163-4)
  • 7 TABLET in 1 BOTTLE (71335-1163-5)
  • 28 TABLET in 1 BOTTLE (71335-1163-6)
  • 1 TABLET in 1 BOTTLE (71335-1163-7)
  • 12 TABLET in 1 BOTTLE (71335-1163-8)
  • 14 TABLET in 1 BOTTLE (71335-1163-9)
source: ndc

Packages (10)

71335-1163-0 120 TABLET in 1 BOTTLE (71335-1163-0) 71335-1163-1 90 TABLET in 1 BOTTLE (71335-1163-1) 71335-1163-2 60 TABLET in 1 BOTTLE (71335-1163-2) 71335-1163-3 30 TABLET in 1 BOTTLE (71335-1163-3) 71335-1163-4 20 TABLET in 1 BOTTLE (71335-1163-4) 71335-1163-5 7 TABLET in 1 BOTTLE (71335-1163-5) 71335-1163-6 28 TABLET in 1 BOTTLE (71335-1163-6) 71335-1163-7 1 TABLET in 1 BOTTLE (71335-1163-7) 71335-1163-8 12 TABLET in 1 BOTTLE (71335-1163-8) 71335-1163-9 14 TABLET in 1 BOTTLE (71335-1163-9)

Ingredients (1)

buprenorphine hydrochloride (8 mg/1)

Linked Drug Pages (1)

Buprenorphine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "4ee49cc8-55ca-4274-9ea6-70d7891d8853", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351265"], "spl_set_id": ["d5a8c41e-413e-4d48-9739-d158e5681dd0"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (71335-1163-0)", "package_ndc": "71335-1163-0", "marketing_start_date": "20240517"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1163-1)", "package_ndc": "71335-1163-1", "marketing_start_date": "20190321"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1163-2)", "package_ndc": "71335-1163-2", "marketing_start_date": "20190424"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1163-3)", "package_ndc": "71335-1163-3", "marketing_start_date": "20190401"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71335-1163-4)", "package_ndc": "71335-1163-4", "marketing_start_date": "20240517"}, {"sample": false, "description": "7 TABLET in 1 BOTTLE (71335-1163-5)", "package_ndc": "71335-1163-5", "marketing_start_date": "20240517"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71335-1163-6)", "package_ndc": "71335-1163-6", "marketing_start_date": "20240517"}, {"sample": false, "description": "1 TABLET in 1 BOTTLE (71335-1163-7)", "package_ndc": "71335-1163-7", "marketing_start_date": "20240517"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (71335-1163-8)", "package_ndc": "71335-1163-8", "marketing_start_date": "20240517"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (71335-1163-9)", "package_ndc": "71335-1163-9", "marketing_start_date": "20240517"}], "brand_name": "Buprenorphine HCl", "product_id": "71335-1163_4ee49cc8-55ca-4274-9ea6-70d7891d8853", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "71335-1163", "dea_schedule": "CIII", "generic_name": "Buprenorphine HCl", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine HCl", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA078633", "marketing_category": "ANDA", "marketing_start_date": "20091008", "listing_expiration_date": "20261231"}