buprenorphine and naloxone

Generic: buprenorphine and naloxone

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone
Generic Name buprenorphine and naloxone
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

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

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-3154
Product ID 0228-3154_f8429e6b-f73d-4f29-8e2e-f8910cfba41d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091422
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2013-03-04

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 02283154
Hyphenated Format 0228-3154

Supplemental Identifiers

RxCUI
351266 351267
UNII
5Q187997EE 56W8MW3EN1

Packaging Origin

Original Packager
true

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 ANDA091422 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0228-3154-03)
source: ndc

Packages (1)

0228-3154-03 30 TABLET in 1 BOTTLE (0228-3154-03)

Ingredients (2)

buprenorphine hydrochloride (2 mg/1) naloxone hydrochloride dihydrate (.5 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": "f8429e6b-f73d-4f29-8e2e-f8910cfba41d", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["6cccf229-9611-4b6f-8f1b-acc8ff1ed3f8"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0228-3154-03)", "package_ndc": "0228-3154-03", "marketing_start_date": "20130304"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "0228-3154_f8429e6b-f73d-4f29-8e2e-f8910cfba41d", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0228-3154", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": ".5 mg/1"}], "application_number": "ANDA091422", "marketing_category": "ANDA", "marketing_start_date": "20130304", "listing_expiration_date": "20271231"}