buprenorphine

Generic: buprenorphine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler american health packaging
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 2 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-481
Product ID 60687-481_2a815afd-4f27-120b-e063-6394a90a82a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207276
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2020-02-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687481
Hyphenated Format 60687-481

Supplemental Identifiers

RxCUI
351264 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
  • 2 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-481-21) / 1 TABLET in 1 BLISTER PACK (60687-481-11)
source: ndc

Packages (1)

60687-481-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-481-21) / 1 TABLET in 1 BLISTER PACK (60687-481-11)

Ingredients (1)

buprenorphine hydrochloride (2 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": "2a815afd-4f27-120b-e063-6394a90a82a0", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351264", "351265"], "spl_set_id": ["8d38f7aa-da0b-40ad-b0d1-4284c71042ed"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-481-21)  / 1 TABLET in 1 BLISTER PACK (60687-481-11)", "package_ndc": "60687-481-21", "marketing_start_date": "20200206"}], "brand_name": "Buprenorphine", "product_id": "60687-481_2a815afd-4f27-120b-e063-6394a90a82a0", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "60687-481", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA207276", "marketing_category": "ANDA", "marketing_start_date": "20200206", "listing_expiration_date": "20261231"}