Fentanyl system

Product NDC
47781-424
11-digit product format
477810424
Labeler code
47781
Product ID
47781-424_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
25 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…

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
ndc (product): 47781-424

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL25 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
47781-424-11Fentanyl system1 in 1 POUCHPATCH127
47781-424-47Fentanyl system5 in 1 CARTONPATCH527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-424-11EA - Each47781-424d30519b6-b1ad-4fa1-9719-ab088bea3c9e12018-05-09
47781-424-47EA - Each47781-4243d8dc1b9-9bfb-4a3f-8a55-45edffe30b5812016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-424FENTANYL SYSTEM (FENTANYL) PATCH [ALVOGEN]24Current NDC, Legacy NDC, 2 package rows20241027_242759ef-cb6d-4e3e-9f8d-5e31efa1f289.zip

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
47781-424-11477810424111 in 1 POUCHHistorical
47781-424-47477810424475 POUCH in 1 CARTON (47781-424-47) / 1 PATCH in 1 POUCH (47781-424-11) 5 pouch2016-11-040000-00-00NoNoCurrent