buprenorphine

Generic: buprenorphine

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

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
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 50090-5805
Product ID 50090-5805_94b57515-d361-4f99-a7e4-fc5f609426c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207276
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2017-10-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500905805
Hyphenated Format 50090-5805

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 (source: ndc)
Generic Name buprenorphine (source: ndc)
Application Number ANDA207276 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50090-5805-0)
source: ndc

Packages (1)

50090-5805-0 30 TABLET in 1 BOTTLE (50090-5805-0)

Ingredients (1)

buprenorphine hydrochloride (8 mg/1)

Linked Drug Pages (1)

BUPRENORPHINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "94b57515-d361-4f99-a7e4-fc5f609426c3", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351265"], "spl_set_id": ["bfb02ea5-22f2-432e-afc8-f1dbe2ea0614"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-5805-0)", "package_ndc": "50090-5805-0", "marketing_start_date": "20211015"}], "brand_name": "BUPRENORPHINE", "product_id": "50090-5805_94b57515-d361-4f99-a7e4-fc5f609426c3", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "50090-5805", "dea_schedule": "CIII", "generic_name": "BUPRENORPHINE", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPRENORPHINE", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA207276", "marketing_category": "ANDA", "marketing_start_date": "20171025", "listing_expiration_date": "20271231"}