Home NDC 3215-7705 FENTANYL
Product NDC 3215-7705
11-digit product format 032157705
Labeler code 3215
Product ID 3215-7705_4edfc77d-dee4-611b-e063-6294a90a47f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FENTANYL
Dosage form PATCH, EXTENDED RELEASE
Route TRANSDERMAL
Labeler Aveva Drug Delivery Systems Inc.
Application ANDA077449
Marketing category ANDA
Marketing start 2025-02-10
Substance FENTANYL
Active strength 62.5 ug/h
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 45 .
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 · 360 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 2026-11-14 07:37:17 2026-10 A077449-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A077449-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A077449-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A077449-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A077449-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-09-11 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A077449-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A077449-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A077449-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A077449-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077449-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077449-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077449-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2008-10-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077449-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2015-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077449-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077449-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077449-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2017-12-06 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 320 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base FENTANYL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENTANYL 62.5 ug/h
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 · 8 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 1603495 Internal RxNorm lookup 1603498 Internal RxNorm lookup 1603501 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 3215-7705-01 FENTANYL 1 in 1 POUCH PATCH, EXTENDED RELEASE 1 2 3215-7705-01 FENTANYL 72 h in 1 PATCH PATCH, EXTENDED RELEASE 72 2 3215-7705-05 FENTANYL 5 in 1 CARTON PATCH, EXTENDED RELEASE 5 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 3215-7705-01 03215770501 1 in 1 POUCH Historical 3215-7705-05 03215770505 5 POUCH in 1 CARTON (3215-7705-05) / 1 PATCH in 1 POUCH (3215-7705-01) / 72 h in 1 PATCH 5 pouch 2025-02-10 No No Current