Home NDC 47781-424 Fentanyl system
Product NDC 47781-424
11-digit product format 477810424
Labeler code 47781
Product ID 47781-424_4b8493ea-0ce4-6949-e063-6294a90a8861
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fentanyl
Dosage form PATCH
Route TRANSDERMAL
Labeler ALVOGEN
Application ANDA202097
Marketing category ANDA
Marketing start 2016-11-04
Substance FENTANYL
Active strength 25 ug/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202097-001 FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04 A202097-002 FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04 A202097-003 FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04 A202097-004 FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04 A202097-005 FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
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 2026-08-01 22:54:32 2026-06 A202097-001 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A202097-002 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A202097-003 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A202097-004 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A202097-005 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2016-11-04 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Fentanyl system
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENTANYL 25 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UF599785JZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197696 Internal RxNorm lookup 245134 Internal RxNorm lookup 245135 Internal RxNorm lookup 245136 Internal RxNorm lookup 577057 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47781-424-11 Fentanyl system 1 in 1 POUCH PATCH 1 27 47781-424-47 Fentanyl system 5 in 1 CARTON PATCH 5 27
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47781-424 FENTANYL SYSTEM (FENTANYL) PATCH [ALVOGEN] 24 Current NDC, Legacy NDC, 2 package rows 20241027_242759ef-cb6d-4e3e-9f8d-5e31efa1f289.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47781-424-11 47781042411 1 in 1 POUCH Historical 47781-424-47 47781042447 5 POUCH in 1 CARTON (47781-424-47) / 1 PATCH in 1 POUCH (47781-424-11) 5 pouch 2016-11-04 0000-00-00 No No Current