Home NDC 63629-5492 FENTANYL TRANSDERMAL SYSTEM
Product NDC 63629-5492
11-digit product format 636295492
Labeler code 63629
Product ID 63629-5492_5fd288e9-8f19-474c-a00f-3a86d2ce5358
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fentanyl transdermal system
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler Bryant Ranch Prepack
Application ANDA077154
Marketing category ANDA
Marketing start 2011-06-06
Marketing end 0000-00-00
Substance FENTANYL
Active strength 50 ug/h
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2019-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-5492-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63629-5492-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63629-5492-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63629-5492-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63629-5492-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63629-5492-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63629-5492-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63629-5492-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63629-5492-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63629-5492-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63629-5492-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63629-5492-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 63629-5492-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 63629-5492-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 63629-5492-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63629-5492-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63629-5492-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-5492-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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.
FDA-Initiated Inactive NDC Indexing# 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] 1001 FENTANYL ACTIVE MOIETY UF599785JZ FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1001 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1001 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1001 DIPROPYLENE GLYCOL INACTIVE INGREDIENT E107L85C40 FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1001 ETHYLENE-VINYL ACETATE COPOLYMER (19% VINYLACETATE) INACTIVE INGREDIENT JK6142KK4O FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1001 HEPTANE INACTIVE INGREDIENT 456148SDMJ FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1001 HYDROXYPROPYL CELLULOSE (TYPE E) INACTIVE INGREDIENT 66O7AQV0RT FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] 1001
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.