buprenorphine hcl and naloxone hcl

Generic: buprenorphine and naloxone

Labeler: avpak
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 avpak
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

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

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-145
Product ID 50268-145_47e23f4e-d4aa-7af1-e063-6394a90a2f05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203136
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2016-12-08

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 50268145
Hyphenated Format 50268-145

Supplemental Identifiers

RxCUI
351266 351267
UNII
5Q187997EE 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 and naloxone hcl (source: ndc)
Generic Name buprenorphine and naloxone (source: ndc)
Application Number ANDA203136 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-145-15) / 1 TABLET in 1 BLISTER PACK (50268-145-11)
source: ndc

Packages (1)

50268-145-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-145-15) / 1 TABLET in 1 BLISTER PACK (50268-145-11)

Ingredients (2)

buprenorphine hydrochloride (8 mg/1) naloxone hydrochloride dihydrate (2 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": "47e23f4e-d4aa-7af1-e063-6394a90a2f05", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["b955054b-b37d-4079-4fed-5939b763ecb4"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-145-15)  / 1 TABLET in 1 BLISTER PACK (50268-145-11)", "package_ndc": "50268-145-15", "marketing_start_date": "20161208"}], "brand_name": "Buprenorphine HCl and Naloxone HCl", "product_id": "50268-145_47e23f4e-d4aa-7af1-e063-6394a90a2f05", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "50268-145", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine HCl and Naloxone HCl", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "2 mg/1"}], "application_number": "ANDA203136", "marketing_category": "ANDA", "marketing_start_date": "20161208", "listing_expiration_date": "20271231"}