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 hydrochloride 8 mg/1, naloxone hydrochloride dihydrate 2 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9483
Product ID 63629-9483_6529cd98-61bf-430c-8001-c591d52dfa23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205601
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2020-04-13

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 636299483
Hyphenated Format 63629-9483

Supplemental Identifiers

RxCUI
351267
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 and naloxone (source: ndc)
Generic Name buprenorphine and naloxone (source: ndc)
Application Number ANDA205601 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (63629-9483-1)
source: ndc

Packages (1)

63629-9483-1 30 TABLET in 1 BOTTLE, PLASTIC (63629-9483-1)

Ingredients (2)

buprenorphine hydrochloride (8 mg/1) naloxone hydrochloride dihydrate (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": "6529cd98-61bf-430c-8001-c591d52dfa23", "openfda": {"unii": ["56W8MW3EN1", "5Q187997EE"], "rxcui": ["351267"], "spl_set_id": ["dd3bfccd-86a1-413f-affd-187f81dd07aa"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (63629-9483-1)", "package_ndc": "63629-9483-1", "marketing_start_date": "20221212"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "63629-9483_6529cd98-61bf-430c-8001-c591d52dfa23", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "63629-9483", "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 HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "2 mg/1"}], "application_number": "ANDA205601", "marketing_category": "ANDA", "marketing_start_date": "20200413", "listing_expiration_date": "20261231"}