Home DailyMed 781f53dd-9031-461d-8ed8-7f2b72509f61 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:05:10
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 A076258-001 FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 A076258-002 FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 A076258-003 FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 A076258-004 FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 A076258-005 FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2007-01-23 A076258-006 FENTANYL-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 A076258-007 FENTANYL-62 FENTANYL 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 A076258-008 FENTANYL-87 FENTANYL 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29
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 A076258-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A076258-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A076258-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A076258-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A076258-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2007-01-23 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A076258-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A076258-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A076258-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A076258-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076258-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076258-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076258-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076258-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2007-01-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076258-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076258-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076258-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076258-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076258-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076258-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076258-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076258-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2007-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076258-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076258-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076258-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076258-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076258-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076258-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076258-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076258-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2007-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076258-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076258-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076258-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076258-001 FENTANYL-25 25MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076258-002 FENTANYL-50 50MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076258-003 FENTANYL-75 75MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076258-004 FENTANYL-100 100MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2005-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076258-005 FENTANYL-12 12.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2007-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076258-006 FENTANYL-37 37.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076258-007 FENTANYL-62 62.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076258-008 FENTANYL-87 87.5MCG/HR FILM, EXTENDED RELEASE / TRANSDERMAL AB 2014-12-29 011fe1cb6892…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 9 · 349 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.