Transmucosal Fentanyl Citrate

Product NDC: 52959-566
11-digit product format: 529590566
Labeler code: 52959
Product ID: 52959-566_319f79f5-a83e-4c51-b362-c01eb43d5ed6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fentanyl citrate
Dosage form: LOZENGE
Route: ORAL; TRANSMUCOSAL
Labeler: H.J. Harkins Company, Inc.
Application: NDA020747
Marketing category: NDA
Marketing start: 2006-09-06
Marketing end: 0000-00-00
Substance: FENTANYL CITRATE
Active strength: 1200 1/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2017-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52959-566		I	Inactivated by FDA		2026-08-07
excluded package	package	52959-566	52959-566-30	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-566-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-566-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-566-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-566-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-566-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-566-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-566-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-566-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-566-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-566-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-566-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-566-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-566-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-566-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-566-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-566-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-566-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-566-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-566-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-566-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	52959-566-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	52959-566-30	`110d247fa046…`	`a55b01930146…`

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3	Product name	1	20231002
a8df478d-5b88-9654-981b-87dff14dda8b	Product name	2	20190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57	Product name	2	20180118
bb365072-425e-ca0a-021e-fd8b78162502	Product name	2	20161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6	Product name	2	20160104
739fa0ac-b690-63c4-9904-e20dffbf78f9	Product name	1	20140508
7763fcbb-367d-ed06-b37f-e1529b6241be	Product name	1	20140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-566-30	2019-11-13	C162847	48780-1	97449f38-b5c1-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-566-01	Transmucosal Fentanyl Citrate	1 in 1 BLISTER PACK	LOZENGE	1		1
52959-566-30	Transmucosal Fentanyl Citrate	30 in 1 CARTON	LOZENGE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-566-30	EA - Each	52959-566	7ac4f00c-bf56-48ef-9fce-be90a468285f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
FENTANYL CITRATE	ACTIVE INGREDIENT	MUN5LYG46H	TRANSMUCOSAL FENTANYL CITRATE (FENTANYL CITRATE) LOZENGE [H.J. HARKINS COMPANY, INC.]	1
FENTANYL	ACTIVE MOIETY	UF599785JZ	TRANSMUCOSAL FENTANYL CITRATE (FENTANYL CITRATE) LOZENGE [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-566	TRANSMUCOSAL FENTANYL CITRATE (FENTANYL CITRATE) LOZENGE [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 2 package rows	20111216_e4ce209d-3f8c-4ac4-bec1-2525a93708bc.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310293	fentaNYL citrate 1200 MCG Oral Lozenge	PSN	e4ce209d-3f8c-4ac4-bec1-2525a93708bc	1
310297	fentaNYL citrate 400 MCG Oral Lozenge	PSN	e4ce209d-3f8c-4ac4-bec1-2525a93708bc	1
313992	fentaNYL citrate 600 MCG Oral Lozenge	PSN	e4ce209d-3f8c-4ac4-bec1-2525a93708bc	1
310297	fentanyl 0.4 MG Oral Lozenge	SCD	e4ce209d-3f8c-4ac4-bec1-2525a93708bc	1
313992	fentanyl 0.6 MG Oral Lozenge	SCD	e4ce209d-3f8c-4ac4-bec1-2525a93708bc	1
310293	fentanyl 1.2 MG Oral Lozenge	SCD	e4ce209d-3f8c-4ac4-bec1-2525a93708bc	1
310293	fentanyl (as fentanyl citrate) 1200 MCG Oral Lozenge	SY	e4ce209d-3f8c-4ac4-bec1-2525a93708bc	1
310297	fentanyl (as fentanyl citrate) 400 MCG Oral Lozenge	SY	e4ce209d-3f8c-4ac4-bec1-2525a93708bc	1
313992	fentanyl (as fentanyl citrate) 600 MCG Oral Lozenge	SY	e4ce209d-3f8c-4ac4-bec1-2525a93708bc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-566-01	52959056601	1 in 1 BLISTER PACK	Historical
52959-566-30	52959056630	30 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Transmucosal Fentanyl Citrate - H.J. Harkins Company, Inc. \| Cephalon Inc.	H.J. Harkins Company, Inc. \| Cephalon Inc.	2011-09-06	HUMAN PRESCRIPTION DRUG LABEL	1