Home NDC 0406-9000 FENTANYL TRANSDERMAL
Product NDC 0406-9000
11-digit product format 004069000
Labeler code 0406
Product ID 0406-9000_301a8c6d-a664-4eac-9c9e-8c47eb34dae4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fentanyl transdermal
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler SpecGx LLC
Application ANDA077154
Marketing category ANDA
Marketing start 2011-02-09
Marketing end 0000-00-00
Substance FENTANYL
Active strength 100 ug/h
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2022-12-31
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 · 24 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 0406-9000-76 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 0406-9000-76 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0406-9000-76 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0406-9000-76 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0406-9000-76 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0406-9000-76 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0406-9000-76 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0406-9000-76 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0406-9000-76 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0406-9000-76 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0406-9000-76 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0406-9000-76 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077154-001 FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB RS 2011-02-09 A077154-002 FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 A077154-003 FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 A077154-004 FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 A077154-005 FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-06-11 A077154-006 FENTANYL-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 A077154-007 FENTANYL-62 FENTANYL 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 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 8 · 300 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 2026-10-15 13:18:30 2026-09 A077154-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB RS 2011-02-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077154-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077154-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077154-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077154-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-06-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077154-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077154-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077154-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB RS 2011-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077154-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077154-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077154-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077154-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077154-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077154-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077154-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB RS 2011-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077154-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077154-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077154-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077154-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077154-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077154-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077154-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB RS 2011-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077154-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077154-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077154-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077154-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077154-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077154-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077154-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB RS 2011-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077154-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077154-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077154-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077154-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077154-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077154-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2020-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077154-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB RS 2011-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077154-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077154-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077154-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2011-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077154-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-06-11 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 300 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FENTANYL ACTIVE INGREDIENT UF599785JZ FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1000 FENTANYL ACTIVE MOIETY UF599785JZ FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1000 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1000 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1000 DIPROPYLENE GLYCOL INACTIVE INGREDIENT E107L85C40 FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1000 ETHYLENE-VINYL ACETATE COPOLYMER (19% VINYLACETATE) INACTIVE INGREDIENT JK6142KK4O FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1000 HEPTANE INACTIVE INGREDIENT 456148SDMJ FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1000 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1000 FENTANYL ACTIVE INGREDIENT UF599785JZ FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 2 FENTANYL ACTIVE MOIETY UF599785JZ FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 2 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 2 DIPROPYLENE GLYCOL INACTIVE INGREDIENT E107L85C40 FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 2 ETHYLENE-VINYL ACETATE COPOLYMER (19% VINYLACETATE) INACTIVE INGREDIENT JK6142KK4O FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 2 HEPTANE INACTIVE INGREDIENT 456148SDMJ FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 2
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 · 1 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 0406-9000-76 00406900076 5 POUCH in 1 CARTON (0406-9000-76) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH 5 pouch 2011-02-09 0000-00-00 No No Current