fentanyl

Generic: fentanyl

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

Drug Facts

Product Profile

Brand Name fentanyl
Generic Name fentanyl
Labeler mylan pharmaceuticals inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

fentanyl 50 ug/h

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-9122
Product ID 0378-9122_a6e21c86-57e5-4be5-b1bb-c894893991b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076258
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2005-01-31

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 03789122
Hyphenated Format 0378-9122

Supplemental Identifiers

RxCUI
197696 245134 245135 245136 577057 1603495 1603498 1603501
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 (source: ndc)
Generic Name fentanyl (source: ndc)
Application Number ANDA076258 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 50 ug/h
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (0378-9122-98) / 1 PATCH in 1 POUCH (0378-9122-16) / 72 h in 1 PATCH
source: ndc

Packages (1)

0378-9122-98 5 POUCH in 1 CARTON (0378-9122-98) / 1 PATCH in 1 POUCH (0378-9122-16) / 72 h in 1 PATCH

Ingredients (1)

fentanyl (50 ug/h)

Linked Drug Pages (1)

FENTANYL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "a6e21c86-57e5-4be5-b1bb-c894893991b2", "openfda": {"nui": ["N0000175684", "N0000175690"], "unii": ["UF599785JZ"], "rxcui": ["197696", "245134", "245135", "245136", "577057", "1603495", "1603498", "1603501"], "spl_set_id": ["2a2238e9-4b5d-c56d-8663-dd354ff9ae0c"], "pharm_class_epc": ["Opioid Agonist [EPC]"], "pharm_class_moa": ["Full Opioid Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (0378-9122-98)  / 1 PATCH in 1 POUCH (0378-9122-16)  / 72 h in 1 PATCH", "package_ndc": "0378-9122-98", "marketing_start_date": "20050131"}], "brand_name": "FENTANYL", "product_id": "0378-9122_a6e21c86-57e5-4be5-b1bb-c894893991b2", "dosage_form": "PATCH", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0378-9122", "dea_schedule": "CII", "generic_name": "FENTANYL", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENTANYL", "active_ingredients": [{"name": "FENTANYL", "strength": "50 ug/h"}], "application_number": "ANDA076258", "marketing_category": "ANDA", "marketing_start_date": "20050131", "listing_expiration_date": "20271231"}