zubsolv

Generic: buprenorphine hydrochloride and naloxone hydrochloride

Labeler: orexo us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zubsolv
Generic Name buprenorphine hydrochloride and naloxone hydrochloride
Labeler orexo us, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride .7 mg/1, naloxone hydrochloride .18 mg/1

Manufacturer
Orexo US, Inc.

Identifiers & Regulatory

Product NDC 54123-907
Product ID 54123-907_8c67e97f-118f-4226-972a-a9031ef6f5ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204242
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2013-07-04

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 54123907
Hyphenated Format 54123-907

Supplemental Identifiers

RxCUI
1431076 1431083 1431102 1431104 1597568 1597570 1597573 1597575 1666338 1666385 1864412 1864414
UNII
56W8MW3EN1 F850569PQR

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 zubsolv (source: ndc)
Generic Name buprenorphine hydrochloride and naloxone hydrochloride (source: ndc)
Application Number NDA204242 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • .7 mg/1
  • .18 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (54123-907-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

54123-907-30 3 BLISTER PACK in 1 CARTON (54123-907-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (2)

buprenorphine hydrochloride (.7 mg/1) naloxone hydrochloride (.18 mg/1)

Linked Drug Pages (1)

Zubsolv ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "8c67e97f-118f-4226-972a-a9031ef6f5ce", "openfda": {"unii": ["56W8MW3EN1", "F850569PQR"], "rxcui": ["1431076", "1431083", "1431102", "1431104", "1597568", "1597570", "1597573", "1597575", "1666338", "1666385", "1864412", "1864414"], "spl_set_id": ["5f5cfcfe-d52b-49e6-8fe4-550477332dd2"], "manufacturer_name": ["Orexo US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (54123-907-30)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "54123-907-30", "marketing_start_date": "20130704"}], "brand_name": "Zubsolv", "product_id": "54123-907_8c67e97f-118f-4226-972a-a9031ef6f5ce", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "54123-907", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride and naloxone hydrochloride", "labeler_name": "Orexo US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zubsolv", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": ".7 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE", "strength": ".18 mg/1"}], "application_number": "NDA204242", "marketing_category": "NDA", "marketing_start_date": "20130704", "listing_expiration_date": "20261231"}