buprenorphine hcl and naloxone hcl

Generic: buprenorphine and naloxone

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

Drug Facts

Product Profile

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

buprenorphine hydrochloride 2 mg/1, naloxone hydrochloride dihydrate .5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1514
Product ID 71335-1514_0816af83-3c98-4df8-9089-a9c4ea4c677f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203136
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2013-02-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713351514
Hyphenated Format 71335-1514

Supplemental Identifiers

RxCUI
351266
UNII
56W8MW3EN1 5Q187997EE

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 and naloxone hcl (source: ndc)
Generic Name buprenorphine and naloxone (source: ndc)
Application Number ANDA203136 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71335-1514-1)
  • 10 TABLET in 1 BOTTLE (71335-1514-2)
source: ndc

Packages (2)

71335-1514-1 30 TABLET in 1 BOTTLE (71335-1514-1) 71335-1514-2 10 TABLET in 1 BOTTLE (71335-1514-2)

Ingredients (2)

buprenorphine hydrochloride (2 mg/1) naloxone hydrochloride dihydrate (.5 mg/1)

Linked Drug Pages (1)

Buprenorphine HCl and Naloxone HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "0816af83-3c98-4df8-9089-a9c4ea4c677f", "openfda": {"unii": ["56W8MW3EN1", "5Q187997EE"], "rxcui": ["351266"], "spl_set_id": ["e82e2d74-33a8-4894-82f6-788fc0f9feec"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1514-1)", "package_ndc": "71335-1514-1", "marketing_start_date": "20200217"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (71335-1514-2)", "package_ndc": "71335-1514-2", "marketing_start_date": "20220921"}], "brand_name": "Buprenorphine HCl and Naloxone HCl", "product_id": "71335-1514_0816af83-3c98-4df8-9089-a9c4ea4c677f", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "71335-1514", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine HCl and Naloxone HCl", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": ".5 mg/1"}], "application_number": "ANDA203136", "marketing_category": "ANDA", "marketing_start_date": "20130222", "listing_expiration_date": "20261231"}