buprenorphine

Generic: buprenorphine

Labeler: clinical solutions wholesale, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler clinical solutions wholesale, llc
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1

Manufacturer
Clinical Solutions Wholesale, LLC

Identifiers & Regulatory

Product NDC 58118-0460
Product ID 58118-0460_2d44842e-3a16-3f1d-e063-6394a90acd3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201760
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2016-02-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 581180460
Hyphenated Format 58118-0460

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 ANDA201760 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (58118-0460-8)
source: ndc

Packages (1)

58118-0460-8 30 TABLET in 1 BLISTER PACK (58118-0460-8)

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": "2d44842e-3a16-3f1d-e063-6394a90acd3d", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351265"], "spl_set_id": ["023c7816-21b1-4f85-be36-9e32d5935c19"], "manufacturer_name": ["Clinical Solutions Wholesale, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (58118-0460-8)", "package_ndc": "58118-0460-8", "marketing_start_date": "20250203"}], "brand_name": "Buprenorphine", "product_id": "58118-0460_2d44842e-3a16-3f1d-e063-6394a90acd3d", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "58118-0460", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "Clinical Solutions Wholesale, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA201760", "marketing_category": "ANDA", "marketing_start_date": "20160217", "listing_expiration_date": "20261231"}