Fentanyl system

Product NDC
47781-428
11-digit product format
477810428
Labeler code
47781
Product ID
47781-428_4b8493ea-0ce4-6949-e063-6294a90a8861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
ALVOGEN
Application
ANDA202097
Marketing category
ANDA
Marketing start
2016-11-04
Substance
FENTANYL
Active strength
100 ug/1
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 · 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.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202097-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202097-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202097-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202097-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202097-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202097-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202097-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202097-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202097-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202097-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202097-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202097-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202097-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202097-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202097-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202097-005AB15bbf6a4d5a75…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL100 ug/1

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 · 5 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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
242759ef-cb6d-4e3e-9f8d-5e31efa1f289Available 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
47781-428-11Fentanyl system1 in 1 POUCHPATCH127
47781-428-47Fentanyl system5 in 1 CARTONPATCH527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-428-11EA - Each47781-428e79c28b2-a69b-4248-86e4-40a2b2ecbffe12018-09-05
47781-428-47EA - Each47781-428810b4c5c-27d2-4912-aca5-81f474284f8312016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-428FENTANYL SYSTEM (FENTANYL) PATCH [ALVOGEN]24Current NDC, Legacy NDC, 2 package rows20241027_242759ef-cb6d-4e3e-9f8d-5e31efa1f289.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 · 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
ndc (product): 47781-428

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245136fentaNYL 100 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
577057fentaNYL 12 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245134fentaNYL 25 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245135fentaNYL 50 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
197696fentaNYL 75 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
57705772 HR fentanyl 0.012 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
24513472 HR fentanyl 0.025 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
24513572 HR fentanyl 0.05 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
19769672 HR fentanyl 0.075 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
24513672 HR fentanyl 0.1 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245136fentanyl 100 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245136fentanyl 100 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
577057fentanyl 12 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
577057fentanyl 12 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245134fentanyl 25 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245134fentanyl 25 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245135fentanyl 50 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245135fentanyl 50 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
197696fentanyl 75 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
197696fentanyl 75 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-428-11477810428111 in 1 POUCHHistorical
47781-428-47477810428475 POUCH in 1 CARTON (47781-428-47) / 1 PATCH in 1 POUCH (47781-428-11) 5 pouch2016-11-040000-00-00NoNoCurrent