FDA.reportPublic FDA data

FENTANYL

Product NDC
60505-7006
11-digit product format
605057006
Labeler code
60505
Product ID
60505-7006_3667df05-f059-309d-c2e7-1b1be5c9388e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENTANYL
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Apotex Corp.
Application
ANDA077449
Marketing category
ANDA
Marketing start
2013-04-04
Marketing end
2025-12-31
Substance
FENTANYL
Active strength
25 ug/h
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60505-7006DDiscontinued by firm2026-08-07
excluded packagepackage60505-700660505-7006-2DDiscontinued by firm2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077449-001FENTANYL-25FENTANYL25MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20
A077449-002FENTANYL-50FENTANYL50MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20
A077449-003FENTANYL-75FENTANYL75MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20
A077449-004FENTANYL-100FENTANYL100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20
A077449-005FENTANYL-12FENTANYL12.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-11
A077449-006FENTANYL-37FENTANYL37.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06
A077449-007FENTANYL-62FENTANYL62.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06
A077449-008FENTANYL-87FENTANYL87.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
A077449-001AB
A077449-002AB
A077449-003AB
A077449-004AB
A077449-005AB
A077449-006AB
A077449-007AB
A077449-008AB

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 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 288 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077449-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077449-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077449-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077449-008AB1b8a1b40f171c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
a8df478d-5b88-9654-981b-87dff14dda8bProduct name220190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57Product name220180118
bb365072-425e-ca0a-021e-fd8b78162502Product name220161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6Product name220160104
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-7006-0EA - Each60505-70061f557f76-bb1b-4cef-90f8-bebe8a8e27e812013-03-03
60505-7006-2EA - Each60505-7006ceb6d457-efa3-48e7-ad63-2fe138e668ca12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYLACTIVE INGREDIENTUF599785JZFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
FENTANYLACTIVE MOIETYUF599785JZFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7FENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
POLYISOBUTYLENE (800000 MW)INACTIVE INGREDIENTY132ZOQ9H7FENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
FENTANYLACTIVE INGREDIENTUF599785JZFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
FENTANYLACTIVE MOIETYUF599785JZFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
POLYISOBUTYLENE (800000 MW)INACTIVE INGREDIENTY132ZOQ9H7FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
FENTANYLACTIVE INGREDIENTUF599785JZFENTANYL PATCH, EXTENDED RELEASE [DIRECTRX]1
FENTANYLACTIVE MOIETYUF599785JZFENTANYL PATCH, EXTENDED RELEASE [DIRECTRX]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFENTANYL PATCH, EXTENDED RELEASE [DIRECTRX]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YFENTANYL PATCH, EXTENDED RELEASE [DIRECTRX]1
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7FENTANYL PATCH, EXTENDED RELEASE [DIRECTRX]1
POLYISOBUTYLENE (800000 MW)INACTIVE INGREDIENTY132ZOQ9H7FENTANYL PATCH, EXTENDED RELEASE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-7006FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]17Legacy NDC20230714_0ff70df0-2cda-d96c-42a8-3bf180310498.zip

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENTANYLFENTANYLAveva Drug Delivery Systems Inc.73897c38-e4ec-40bc-9f41-3359ee23a5a82026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077449
application number: ANDA077449
FENTANYLFENTANYLINGENUS PHARMACEUTICALS, LLCbf02ffd0-cc5d-446b-b648-378f6885052f2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077449
application number: ANDA077449

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245134fentaNYL 25 MCG/HR 72HR Transdermal SystemPSNbcf3d225-2404-4cf5-8a58-bb8f27fe2a353
24513472 HR fentanyl 0.025 MG/HR Transdermal SystemSCDbcf3d225-2404-4cf5-8a58-bb8f27fe2a353
245134fentanyl 25 MCG/HR 3 Day Transdermal PatchSYbcf3d225-2404-4cf5-8a58-bb8f27fe2a353
245134fentanyl 25 MCG/HR 72HR Transdermal SystemSYbcf3d225-2404-4cf5-8a58-bb8f27fe2a353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-7006-2605057006025 POUCH in 1 CARTON (60505-7006-2) > 1 PATCH in 1 POUCH (60505-7006-0) > 72 h in 1 PATCH5 pouch2013-04-040000-00-00NoNoCurrent