buprenorphine hydrochloride

Generic: buprenorphine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hydrochloride
Generic Name buprenorphine hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7559
Product ID 50090-7559_18fa8a54-6196-4635-a213-f78a9236f3d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090622
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-10-12

Pharmacologic Class

Classes
partial opioid agonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907559
Hyphenated Format 50090-7559

Supplemental Identifiers

RxCUI
351265
UNII
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 hydrochloride (source: ndc)
Generic Name buprenorphine hydrochloride (source: ndc)
Application Number ANDA090622 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50090-7559-0)
source: ndc

Packages (1)

50090-7559-0 30 TABLET in 1 BOTTLE (50090-7559-0)

Ingredients (1)

buprenorphine hydrochloride (8 mg/1)

Linked Drug Pages (1)

buprenorphine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "18fa8a54-6196-4635-a213-f78a9236f3d6", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351265"], "spl_set_id": ["c1398d85-d4bb-4426-8ecf-a50400910d81"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-7559-0)", "package_ndc": "50090-7559-0", "marketing_start_date": "20250527"}], "brand_name": "buprenorphine hydrochloride", "product_id": "50090-7559_18fa8a54-6196-4635-a213-f78a9236f3d6", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "50090-7559", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "buprenorphine hydrochloride", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA090622", "marketing_category": "ANDA", "marketing_start_date": "20231012", "listing_expiration_date": "20261231"}