FENTANYL

Product NDC
3215-7701
11-digit product format
032157701
Labeler code
3215
Product ID
3215-7701_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
2025-01-30
Substance
FENTANYL
Active strength
12 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 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…

Additional Listing Data#

Finished product
Yes
Brand name base
FENTANYL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL12 ug/h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UF599785JZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197696Internal RxNorm lookup
245134Internal RxNorm lookup
245135Internal RxNorm lookup
245136Internal RxNorm lookup
577057Internal RxNorm lookup
1603495Internal RxNorm lookup
1603498Internal RxNorm lookup
1603501Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
73897c38-e4ec-40bc-9f41-3359ee23a5a8Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
3215-7701-01FENTANYL72 h in 1 PATCHPATCH, EXTENDED RELEASE722
3215-7701-01FENTANYL1 in 1 POUCHPATCH, EXTENDED RELEASE12
3215-7701-05FENTANYL5 in 1 CARTONPATCH, EXTENDED RELEASE52

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
ndc (product): 3215-7701
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
245136fentaNYL 100 MCG/HR 72HR Transdermal SystemPSN73897c38-e4ec-40bc-9f41-3359ee23a5a82
577057fentaNYL 12 MCG/HR 72HR Transdermal SystemPSN73897c38-e4ec-40bc-9f41-3359ee23a5a82
245134fentaNYL 25 MCG/HR 72HR Transdermal SystemPSN73897c38-e4ec-40bc-9f41-3359ee23a5a82
1603495fentaNYL 37.5 MCG/HR 72HR Transdermal SystemPSN73897c38-e4ec-40bc-9f41-3359ee23a5a82
245135fentaNYL 50 MCG/HR 72HR Transdermal SystemPSN73897c38-e4ec-40bc-9f41-3359ee23a5a82
1603498fentaNYL 62.5 MCG/HR 72 HR Transdermal SystemPSN73897c38-e4ec-40bc-9f41-3359ee23a5a82
197696fentaNYL 75 MCG/HR 72HR Transdermal SystemPSN73897c38-e4ec-40bc-9f41-3359ee23a5a82
1603501fentaNYL 87.5 MCG/HR 72HR Transdermal SystemPSN73897c38-e4ec-40bc-9f41-3359ee23a5a82
57705772 HR fentanyl 0.012 MG/HR Transdermal SystemSCD73897c38-e4ec-40bc-9f41-3359ee23a5a82
24513472 HR fentanyl 0.025 MG/HR Transdermal SystemSCD73897c38-e4ec-40bc-9f41-3359ee23a5a82
160349572 HR fentanyl 0.0375 MG/HR Transdermal SystemSCD73897c38-e4ec-40bc-9f41-3359ee23a5a82
24513572 HR fentanyl 0.05 MG/HR Transdermal SystemSCD73897c38-e4ec-40bc-9f41-3359ee23a5a82
160349872 HR fentanyl 0.0625 MG/HR Transdermal SystemSCD73897c38-e4ec-40bc-9f41-3359ee23a5a82
19769672 HR fentanyl 0.075 MG/HR Transdermal SystemSCD73897c38-e4ec-40bc-9f41-3359ee23a5a82
160350172 HR fentanyl 0.0875 MG/HR Transdermal SystemSCD73897c38-e4ec-40bc-9f41-3359ee23a5a82
24513672 HR fentanyl 0.1 MG/HR Transdermal SystemSCD73897c38-e4ec-40bc-9f41-3359ee23a5a82
245136fentanyl 100 MCG/HR 3 Day Transdermal PatchSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
245136fentanyl 100 MCG/HR 72HR Transdermal SystemSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
577057fentanyl 12 MCG/HR 3 Day Transdermal PatchSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
577057fentanyl 12 MCG/HR 72HR Transdermal SystemSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
245134fentanyl 25 MCG/HR 3 Day Transdermal PatchSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
245134fentanyl 25 MCG/HR 72HR Transdermal SystemSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
1603495fentanyl 37.5 MCG/HR 3 Day Transdermal PatchSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
1603495fentaNYL 37.5 MCG/HR 72HR Transdermal SystemSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
245135fentanyl 50 MCG/HR 3 Day Transdermal PatchSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
245135fentanyl 50 MCG/HR 72HR Transdermal SystemSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
1603498fentanyl 62.5 MCG/HR 3 Day Transdermal PatchSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
1603498fentanyl 62.5 MCG/HR 72 HR Transdermal SystemSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
197696fentanyl 75 MCG/HR 3 Day Transdermal PatchSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
197696fentanyl 75 MCG/HR 72HR Transdermal SystemSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
1603501fentanyl 87.5 MCG/HR 3 Day Transdermal PatchSY73897c38-e4ec-40bc-9f41-3359ee23a5a82
1603501fentanyl 87.5 MCG/HR 72HR Transdermal SystemSY73897c38-e4ec-40bc-9f41-3359ee23a5a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
3215-7701-010321577010172 h in 1 PATCH72 hHistorical
3215-7701-05032157701055 POUCH in 1 CARTON (3215-7701-05) / 1 PATCH in 1 POUCH (3215-7701-01) / 72 h in 1 PATCH5 pouch2025-01-30NoNoCurrent