buprenorphine sublingual

Generic: buprenorphine sublingual

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

buprenorphine hydrochloride 2 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-579
Product ID 72189-579_2204e135-6a0d-68a2-e063-6394a90ac019
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201760
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2024-09-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189579
Hyphenated Format 72189-579

Supplemental Identifiers

RxCUI
351264
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 (source: ndc)
Generic Name buprenorphine sublingual (source: ndc)
Application Number ANDA201760 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (72189-579-60)
source: ndc

Packages (1)

72189-579-60 60 TABLET in 1 BOTTLE (72189-579-60)

Ingredients (1)

buprenorphine hydrochloride (2 mg/1)

Linked Drug Pages (1)

Buprenorphine Sublingual ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "2204e135-6a0d-68a2-e063-6394a90ac019", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351264"], "spl_set_id": ["2204e135-6a0c-68a2-e063-6394a90ac019"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-579-60)", "package_ndc": "72189-579-60", "marketing_start_date": "20240913"}], "brand_name": "Buprenorphine Sublingual", "product_id": "72189-579_2204e135-6a0d-68a2-e063-6394a90ac019", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "72189-579", "dea_schedule": "CIII", "generic_name": "Buprenorphine Sublingual", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine Sublingual", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA201760", "marketing_category": "ANDA", "marketing_start_date": "20240913", "listing_expiration_date": "20261231"}