ACTIQ

Product NDC
63459-506
11-digit product format
634590506
Labeler code
63459
Product ID
63459-506_3ffd9e45-cf0a-4204-b702-2aa38605a8b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate
Dosage form
LOZENGE
Route
ORAL; TRANSMUCOSAL
Labeler
Cephalon, LLC
Application
NDA020747
Marketing category
NDA
Marketing start
1999-01-20
Marketing end
0000-00-00
Substance
FENTANYL CITRATE
Active strength
600 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#

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 productproduct63459-506DDiscontinued by firm2026-09-14
excluded packagepackage63459-50663459-506-30DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63459-506-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63459-506-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63459-506-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63459-506-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63459-506-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63459-506-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63459-506-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63459-506-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63459-506-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63459-506-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63459-506-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63459-506-30557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020747-001ACTIQFENTANYL CITRATEEQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-002ACTIQFENTANYL CITRATEEQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-003ACTIQFENTANYL CITRATEEQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-004ACTIQFENTANYL CITRATEEQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-005ACTIQFENTANYL CITRATEEQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-006ACTIQFENTANYL CITRATEEQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04

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 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020747-001ACTIQEQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-002ACTIQEQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-003ACTIQEQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-004ACTIQEQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-005ACTIQEQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-006ACTIQEQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-08-18 06:07:402026-07N020747-001ACTIQEQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-002ACTIQEQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-003ACTIQEQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-004ACTIQEQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-005ACTIQEQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-006ACTIQEQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020747-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020747-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020747-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020747-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020747-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-006AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020747-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020747-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020747-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020747-004AB187673890dc5c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-506-01EA - Each63459-506f11e8acb-18db-4df1-b313-5c557296f12c12013-02-13
63459-506-30EA - Each63459-506123fa81e-6b79-4396-9736-274c5eef6f7112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYL CITRATEACTIVE INGREDIENTMUN5LYG46HACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
FENTANYLACTIVE MOIETYUF599785JZACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
DEXTRATESINACTIVE INGREDIENTG263MI44RUACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
SUCROSEINACTIVE INGREDIENTC151H8M554ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-506ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, LLC]24Legacy NDC20240828_90b94524-f913-48b3-3771-7b2fcffd888a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63459-506-306345905063030 BLISTER PACK in 1 CARTON (63459-506-30) > 1 LOZENGE in 1 BLISTER PACK (63459-506-01) 30 blister pack1999-01-200000-00-00NoNoCurrent