buprenorphine

Generic: buprenorphine

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-3153
Product ID 0228-3153_eb9e7c72-45fb-4455-a405-027cf06caac6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090819
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2015-02-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02283153
Hyphenated Format 0228-3153

Supplemental Identifiers

RxCUI
351264 351265
UNII
56W8MW3EN1

Packaging Origin

Original Packager
true

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 ANDA090819 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0228-3153-03)
source: ndc

Packages (1)

0228-3153-03 30 TABLET in 1 BOTTLE (0228-3153-03)

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": "eb9e7c72-45fb-4455-a405-027cf06caac6", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351264", "351265"], "spl_set_id": ["03819118-86f6-4329-adaf-4599e7b71f46"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0228-3153-03)", "package_ndc": "0228-3153-03", "marketing_start_date": "20150410"}], "brand_name": "Buprenorphine", "product_id": "0228-3153_eb9e7c72-45fb-4455-a405-027cf06caac6", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0228-3153", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA090819", "marketing_category": "ANDA", "marketing_start_date": "20150219", "listing_expiration_date": "20271231"}