fentanyl transdermal

Generic: fentanyl transdermal

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fentanyl transdermal
Generic Name fentanyl transdermal
Labeler specgx llc
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

fentanyl 100 ug/h

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-9100
Product ID 0406-9100_60f61c55-abf0-467f-a053-fd87c26baf1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077154
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-05-06

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 04069100
Hyphenated Format 0406-9100

Supplemental Identifiers

RxCUI
197696 245134 245135 245136 577057 1603495 1603498
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 transdermal (source: ndc)
Generic Name fentanyl transdermal (source: ndc)
Application Number ANDA077154 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 100 ug/h
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (0406-9100-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH
source: ndc

Packages (1)

0406-9100-76 5 POUCH in 1 CARTON (0406-9100-76) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH

Ingredients (1)

fentanyl (100 ug/h)

Linked Drug Pages (1)

FENTANYL TRANSDERMAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "60f61c55-abf0-467f-a053-fd87c26baf1f", "openfda": {"nui": ["N0000175684", "N0000175690"], "unii": ["UF599785JZ"], "rxcui": ["197696", "245134", "245135", "245136", "577057", "1603495", "1603498"], "spl_set_id": ["e15a7e9b-8025-49dd-9a6d-bafcccf1959f"], "pharm_class_epc": ["Opioid Agonist [EPC]"], "pharm_class_moa": ["Full Opioid Agonists [MoA]"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (0406-9100-76)  / 1 PATCH in 1 POUCH / 72 h in 1 PATCH", "package_ndc": "0406-9100-76", "marketing_start_date": "20200506"}], "brand_name": "FENTANYL TRANSDERMAL", "product_id": "0406-9100_60f61c55-abf0-467f-a053-fd87c26baf1f", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-9100", "dea_schedule": "CII", "generic_name": "fentanyl transdermal", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENTANYL TRANSDERMAL", "active_ingredients": [{"name": "FENTANYL", "strength": "100 ug/h"}], "application_number": "ANDA077154", "marketing_category": "ANDA", "marketing_start_date": "20200506", "listing_expiration_date": "20261231"}