ACTIQ

Product NDC: 63459-504
Requested package NDC: 63459-504-30
11-digit product format: 634590504
Labeler code: 63459
Product ID: 63459-504_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: 400 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63459-504	63459-504-30	D	Discontinued by firm		2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63459-504	63459-504-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63459-504	63459-504-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020747-001	ACTIQ	FENTANYL CITRATE	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-002	ACTIQ	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-003	ACTIQ	FENTANYL CITRATE	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-004	ACTIQ	FENTANYL CITRATE	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-005	ACTIQ	FENTANYL CITRATE	EQ 1.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-006	ACTIQ	FENTANYL CITRATE	EQ 1.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04

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 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-005	ACTIQ	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020747-006	ACTIQ	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020747-001	ACTIQ	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020747-002	ACTIQ	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020747-003	ACTIQ	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020747-004	ACTIQ	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04	`2680178bc6a6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020747-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020747-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020747-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020747-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020747-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020747-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020747-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020747-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020747-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020747-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020747-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-004	AB	1	`87673890dc5c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63459-504-01	EA - Each	63459-504	1995a3fc-a27a-4d46-af1c-bce2951b8903	1	2013-02-13
63459-504-30	EA - Each	63459-504	b0c186a8-fa76-488b-9412-19a4d4340851	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL CITRATE	ACTIVE INGREDIENT	MUN5LYG46H	ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]	7
FENTANYL	ACTIVE MOIETY	UF599785JZ	ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]	7
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]	7
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]	7
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]	7
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63459-504	ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, LLC]	24	Legacy NDC	20240828_90b94524-f913-48b3-3771-7b2fcffd888a.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fentanyl Citrate	FENTANYL CITRATE	Teva Pharmaceuticals USA, Inc.	78221eab-66fd-4cd8-9c81-af52eb83671c	2026-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020747 application number: NDA020747

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MUN5LYG46H	FENTANYL CITRATE	990-73-8	FENTANYL CITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63459-504-30	63459050430	30 BLISTER PACK in 1 CARTON (63459-504-30) > 1 LOZENGE in 1 BLISTER PACK (63459-504-01)	30 blister pack	1999-01-20	0000-00-00	No	No	Current