buprenorphine transdermal system

Generic: buprenorphine

Labeler: alvogen inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine transdermal system
Generic Name buprenorphine
Labeler alvogen inc.
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

buprenorphine 20 ug/h

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-408
Product ID 47781-408_7f83c8aa-7590-e2fe-4998-55323eadd112
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207490
DEA Schedule ciii
Marketing Start 2022-05-17
Marketing End 2027-01-31

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 47781408
Hyphenated Format 47781-408

Supplemental Identifiers

RxCUI
904870 904876 904880 1432969
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 buprenorphine transdermal system (source: ndc)
Generic Name buprenorphine (source: ndc)
Application Number ANDA207490 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 20 ug/h
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (47781-408-04) / 1 PATCH in 1 POUCH (47781-408-11) / 168 h in 1 PATCH
source: ndc

Packages (1)

47781-408-04 4 POUCH in 1 CARTON (47781-408-04) / 1 PATCH in 1 POUCH (47781-408-11) / 168 h in 1 PATCH

Ingredients (1)

buprenorphine (20 ug/h)

Linked Drug Pages (1)

buprenorphine transdermal system ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "7f83c8aa-7590-e2fe-4998-55323eadd112", "openfda": {"nui": ["N0000175689", "N0000175685"], "unii": ["40D3SCR4GZ"], "rxcui": ["904870", "904876", "904880", "1432969"], "spl_set_id": ["315284b8-32ab-d34a-ea02-f501c6131bcc"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (47781-408-04)  / 1 PATCH in 1 POUCH (47781-408-11)  / 168 h in 1 PATCH", "package_ndc": "47781-408-04", "marketing_end_date": "20270131", "marketing_start_date": "20220829"}], "brand_name": "buprenorphine transdermal system", "product_id": "47781-408_7f83c8aa-7590-e2fe-4998-55323eadd112", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "47781-408", "dea_schedule": "CIII", "generic_name": "buprenorphine", "labeler_name": "Alvogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "buprenorphine transdermal system", "active_ingredients": [{"name": "BUPRENORPHINE", "strength": "20 ug/h"}], "application_number": "ANDA207490", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20220517"}