buprenorphine sublingual c-iii

Generic: buprenorphine sublingual c-iii

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine sublingual c-iii
Generic Name buprenorphine sublingual c-iii
Labeler direct_rx
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-582
Product ID 72189-582_248524c6-4c8c-a450-e063-6394a90a81ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078633
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2024-10-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189582
Hyphenated Format 72189-582

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 sublingual c-iii (source: ndc)
Generic Name buprenorphine sublingual c-iii (source: ndc)
Application Number ANDA078633 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (72189-582-60)
source: ndc

Packages (1)

72189-582-60 60 TABLET in 1 BOTTLE (72189-582-60)

Ingredients (1)

buprenorphine hydrochloride (8 mg/1)

Linked Drug Pages (1)

Buprenorphine Sublingual C-III ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "248524c6-4c8c-a450-e063-6394a90a81ef", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351265"], "spl_set_id": ["248524c6-4c8b-a450-e063-6394a90a81ef"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-582-60)", "package_ndc": "72189-582-60", "marketing_start_date": "20241015"}], "brand_name": "Buprenorphine Sublingual C-III", "product_id": "72189-582_248524c6-4c8c-a450-e063-6394a90a81ef", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "72189-582", "dea_schedule": "CIII", "generic_name": "Buprenorphine Sublingual C-III", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine Sublingual C-III", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA078633", "marketing_category": "ANDA", "marketing_start_date": "20241015", "listing_expiration_date": "20261231"}