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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-597DDiscontinued by firm2026-08-03
excluded packagepackage55700-59755700-597-05DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202097-001FENTANYL-12FENTANYL12.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-002FENTANYL-25FENTANYL25MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-003FENTANYL-50FENTANYL50MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-004FENTANYL-75FENTANYL75MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-005FENTANYL-100FENTANYL100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A202097-001AB
A202097-002AB
A202097-003AB
A202097-004AB
A202097-005AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…
2026-08-01 22:54:322026-06A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…
2026-08-01 22:54:322026-06A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…
2026-08-01 22:54:322026-06A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…
2026-08-01 22:54:322026-06A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202097-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202097-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202097-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202097-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A202097-005AB1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fentanyl systemFENTANYLALVOGEN242759ef-cb6d-4e3e-9f8d-5e31efa1f2892026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202097
application number: ANDA202097

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-597-05EA - Each55700-59752dccaca-94be-42c6-9287-c93fe7f1fc9f12018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-597-05557000597051 POUCH in 1 CARTON (55700-597-05) > 5 PATCH in 1 POUCH1 pouch2018-04-130000-00-00NoNoCurrent