Home NDC 55700-597 Fentanyl System
Product NDC 55700-597
11-digit product format 557000597
Labeler code 55700
Product ID 55700-597_0be26ea2-6947-47b9-8eb0-96b2426607e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fentanyl
Dosage form PATCH
Route TRANSDERMAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA202097
Marketing category ANDA
Marketing start 2018-04-13
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55700-597-05 55700059705 1 POUCH in 1 CARTON (55700-597-05) > 5 PATCH in 1 POUCH 1 pouch 2018-04-13 0000-00-00 No No Current