buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Generic: buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Generic Name buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Labeler specgx llc
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

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

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-8020
Product ID 0406-8020_bd7bf416-c9b0-42fb-9593-077053c1cdd2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207000
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2017-12-13

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 04068020
Hyphenated Format 0406-8020

Supplemental Identifiers

RxCUI
351266 351267
UPC
0304068005039 0304068020032
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 hydrochloride and naloxone hydrochloride dihydrate (source: ndc)
Generic Name buprenorphine hydrochloride and naloxone hydrochloride dihydrate (source: ndc)
Application Number ANDA207000 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (0406-8020-03)
source: ndc

Packages (1)

0406-8020-03 30 TABLET in 1 BOTTLE, PLASTIC (0406-8020-03)

Ingredients (2)

buprenorphine hydrochloride (8 mg/1) naloxone hydrochloride dihydrate (2 mg/1)

Linked Drug Pages (1)

Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "bd7bf416-c9b0-42fb-9593-077053c1cdd2", "openfda": {"upc": ["0304068005039", "0304068020032"], "unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["351266", "351267"], "spl_set_id": ["62abde41-46cb-4e90-a798-23d6531bf9aa"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (0406-8020-03)", "package_ndc": "0406-8020-03", "marketing_start_date": "20171213"}], "brand_name": "Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate", "product_id": "0406-8020_bd7bf416-c9b0-42fb-9593-077053c1cdd2", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0406-8020", "dea_schedule": "CIII", "generic_name": "Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "2 mg/1"}], "application_number": "ANDA207000", "marketing_category": "ANDA", "marketing_start_date": "20171213", "listing_expiration_date": "20261231"}