butrans

Generic: buprenorphine

Labeler: purdue pharma lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name butrans
Generic Name buprenorphine
Labeler purdue pharma lp
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

buprenorphine 7.5 ug/h

Manufacturer
Purdue Pharma LP

Identifiers & Regulatory

Product NDC 59011-757
Product ID 59011-757_ba40a658-eb5f-487f-9405-324bdfce6083
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021306
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2011-02-14

Pharmacologic Class

Established (EPC)
partial opioid agonist [epc]
Mechanism of Action
partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59011757
Hyphenated Format 59011-757

Supplemental Identifiers

RxCUI
904870 904874 904876 904878 904880 904882 1432969 1432971 1542997 1542999
UNII
40D3SCR4GZ
NUI
N0000175689 N0000175685

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 butrans (source: ndc)
Generic Name buprenorphine (source: ndc)
Application Number NDA021306 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 7.5 ug/h
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (59011-757-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
source: ndc

Packages (1)

59011-757-04 4 POUCH in 1 CARTON (59011-757-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH

Ingredients (1)

buprenorphine (7.5 ug/h)

Linked Drug Pages (1)

Butrans ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "ba40a658-eb5f-487f-9405-324bdfce6083", "openfda": {"nui": ["N0000175689", "N0000175685"], "unii": ["40D3SCR4GZ"], "rxcui": ["904870", "904874", "904876", "904878", "904880", "904882", "1432969", "1432971", "1542997", "1542999"], "spl_set_id": ["794aa355-66de-41b8-aedf-f2c40f6bc664"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]"], "manufacturer_name": ["Purdue Pharma LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (59011-757-04)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH", "package_ndc": "59011-757-04", "marketing_start_date": "20110214"}], "brand_name": "Butrans", "product_id": "59011-757_ba40a658-eb5f-487f-9405-324bdfce6083", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "59011-757", "dea_schedule": "CIII", "generic_name": "buprenorphine", "labeler_name": "Purdue Pharma LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butrans", "active_ingredients": [{"name": "BUPRENORPHINE", "strength": "7.5 ug/h"}], "application_number": "NDA021306", "marketing_category": "NDA", "marketing_start_date": "20110214", "listing_expiration_date": "20271231"}