Home NDC 60505-7017 FENTANYL
Product NDC 60505-7017
11-digit product format 605057017
Labeler code 60505
Product ID 60505-7017_3667df05-f059-309d-c2e7-1b1be5c9388e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FENTANYL
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler Apotex Corp.
Application ANDA077449
Marketing category ANDA
Marketing start 2019-07-24
Marketing end 2025-06-30
Substance FENTANYL
Active strength 88 ug/h
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60505-7017-2 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60505-7017-2 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077449-001 FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 A077449-002 FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 A077449-003 FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 A077449-004 FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 A077449-005 FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-09-11 A077449-006 FENTANYL-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 A077449-007 FENTANYL-62 FENTANYL 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 A077449-008 FENTANYL-87 FENTANYL 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 8 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 9 · 344 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A077449-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077449-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077449-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077449-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077449-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077449-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077449-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077449-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077449-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077449-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077449-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077449-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077449-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077449-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077449-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077449-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077449-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077449-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077449-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077449-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077449-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077449-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077449-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077449-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077449-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077449-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077449-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077449-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077449-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077449-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077449-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077449-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077449-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077449-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077449-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077449-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077449-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077449-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077449-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077449-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 304 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-7017 FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.] 17 Legacy NDC 20230714_0ff70df0-2cda-d96c-42a8-3bf180310498.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-7017-2 60505701702 5 POUCH in 1 CARTON (60505-7017-2) > 1 PATCH in 1 POUCH (60505-7017-0) > 72 h in 1 PATCH 5 pouch 2019-07-24 0000-00-00 No No Current