buprenorphine and naloxone (62175-458)

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone

Generic Name buprenorphine and naloxone

Labeler lannett company, inc.

Dosage Form TABLET

Routes

SUBLINGUAL

Active Ingredients

buprenorphine 8 mg/1, naloxone 2 mg/1

Manufacturer

Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 62175-458

Product ID 62175-458_2f25fc02-629e-4539-82b9-f22f6937d72e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205022

DEA Schedule ciii

Listing Expiration 2027-12-31

Marketing Start 2016-09-19

Pharmacologic Class

Established (EPC)

partial opioid agonist [epc] opioid antagonist [epc]

Mechanism of Action

partial opioid agonists [moa] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62175458

Hyphenated Format 62175-458

Supplemental Identifiers

RxCUI

351266 351267

UNII

40D3SCR4GZ 36B82AMQ7N

NUI

N0000175689 N0000175685 N0000175691 N0000000154

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 ANDA205022 (source: ndc)

Routes

SUBLINGUAL

source: ndc

Resolved Composition

Strengths

8 mg/1
2 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (62175-458-32)

source: ndc

Packages (1)

62175-458-32 30 TABLET in 1 BOTTLE (62175-458-32)

Ingredients (2)

buprenorphine (8 mg/1) naloxone (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": "2f25fc02-629e-4539-82b9-f22f6937d72e", "openfda": {"nui": ["N0000175689", "N0000175685", "N0000175691", "N0000000154"], "unii": ["40D3SCR4GZ", "36B82AMQ7N"], "rxcui": ["351266", "351267"], "spl_set_id": ["14eaa94a-cc8a-4e1e-8cfb-5c976c96c606"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]", "Opioid Antagonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]", "Opioid Antagonists [MoA]"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62175-458-32)", "package_ndc": "62175-458-32", "marketing_start_date": "20160919"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "62175-458_2f25fc02-629e-4539-82b9-f22f6937d72e", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "62175-458", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE", "strength": "8 mg/1"}, {"name": "NALOXONE", "strength": "2 mg/1"}], "application_number": "ANDA205022", "marketing_category": "ANDA", "marketing_start_date": "20160919", "listing_expiration_date": "20271231"}