fentanyl system

Generic: fentanyl

Labeler: alvogen
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fentanyl system
Generic Name fentanyl
Labeler alvogen
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

fentanyl 12.5 ug/1

Manufacturer
ALVOGEN

Identifiers & Regulatory

Product NDC 47781-423
Product ID 47781-423_4b8493ea-0ce4-6949-e063-6294a90a8861
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202097
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2016-11-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47781423
Hyphenated Format 47781-423

Supplemental Identifiers

RxCUI
197696 245134 245135 245136 577057
UNII
UF599785JZ
NUI
N0000175684 N0000175690

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 fentanyl system (source: ndc)
Generic Name fentanyl (source: ndc)
Application Number ANDA202097 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 12.5 ug/1
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (47781-423-47) / 1 PATCH in 1 POUCH (47781-423-11)
source: ndc

Packages (1)

47781-423-47 5 POUCH in 1 CARTON (47781-423-47) / 1 PATCH in 1 POUCH (47781-423-11)

Ingredients (1)

fentanyl (12.5 ug/1)

Linked Drug Pages (1)

Fentanyl system ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "4b8493ea-0ce4-6949-e063-6294a90a8861", "openfda": {"nui": ["N0000175684", "N0000175690"], "unii": ["UF599785JZ"], "rxcui": ["197696", "245134", "245135", "245136", "577057"], "spl_set_id": ["242759ef-cb6d-4e3e-9f8d-5e31efa1f289"], "pharm_class_epc": ["Opioid Agonist [EPC]"], "pharm_class_moa": ["Full Opioid Agonists [MoA]"], "manufacturer_name": ["ALVOGEN"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (47781-423-47)  / 1 PATCH in 1 POUCH (47781-423-11)", "package_ndc": "47781-423-47", "marketing_start_date": "20161104"}], "brand_name": "Fentanyl system", "product_id": "47781-423_4b8493ea-0ce4-6949-e063-6294a90a8861", "dosage_form": "PATCH", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "47781-423", "dea_schedule": "CII", "generic_name": "Fentanyl", "labeler_name": "ALVOGEN", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fentanyl system", "active_ingredients": [{"name": "FENTANYL", "strength": "12.5 ug/1"}], "application_number": "ANDA202097", "marketing_category": "ANDA", "marketing_start_date": "20161104", "listing_expiration_date": "20271231"}