FENTANYL

Generic: FENTANYL

Labeler: Apotex Corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name FENTANYL
Generic Name FENTANYL
Labeler Apotex Corp.
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

FENTANYL 50 ug/h

Identifiers & Regulatory

Product NDC 60505-7012
Product ID 60505-7012_005d170d-692f-f040-e063-6394a90aa0a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077449
DEA Schedule CII
Marketing Start 2013-04-04
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605057012
Hyphenated Format 60505-7012

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 ANDA077449 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 50 ug/h
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (60505-7012-2) / 1 PATCH in 1 POUCH (60505-7012-0) / 72 h in 1 PATCH
source: ndc

Packages (1)

60505-7012-2 5 POUCH in 1 CARTON (60505-7012-2) / 1 PATCH in 1 POUCH (60505-7012-0) / 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": "005d170d-692f-f040-e063-6394a90aa0a4", "openfda": {"nui": ["N0000175684", "N0000175690"], "unii": ["UF599785JZ"], "rxcui": ["197696", "245134", "245135", "245136", "577057", "1603495", "1603498", "1603501"], "spl_set_id": ["0ff70df0-2cda-d96c-42a8-3bf180310498"], "pharm_class_epc": ["Opioid Agonist [EPC]"], "pharm_class_moa": ["Full Opioid Agonists [MoA]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (60505-7012-2)  / 1 PATCH in 1 POUCH (60505-7012-0)  / 72 h in 1 PATCH", "package_ndc": "60505-7012-2", "marketing_end_date": "20260228", "marketing_start_date": "20130404"}], "brand_name": "FENTANYL", "product_id": "60505-7012_005d170d-692f-f040-e063-6394a90aa0a4", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "60505-7012", "dea_schedule": "CII", "generic_name": "FENTANYL", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENTANYL", "active_ingredients": [{"name": "FENTANYL", "strength": "50 ug/h"}], "application_number": "ANDA077449", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20130404"}