FENTANYL CITRATE

Product NDC: 0406-9202
Requested package NDC: 0406-9202-30
11-digit product format: 004069202
Labeler code: 0406
Product ID: 0406-9202_d96648d1-25f9-4a86-b771-55d298c5301b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENTANYL CITRATE
Dosage form: LOZENGE
Route: TRANSMUCOSAL
Labeler: SpecGx LLC
Application: ANDA078907
Marketing category: ANDA
Marketing start: 2009-10-30
Marketing end: 0000-00-00
Substance: FENTANYL CITRATE
Active strength: 200 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	0406-9202	0406-9202-30	D	Discontinued by firm		2026-09-14

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078907-001	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-002	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-003	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-004	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-005	FENTANYL CITRATE	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-006	FENTANYL CITRATE	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`

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	A078907-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078907-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078907-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078907-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078907-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078907-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078907-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078907-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078907-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078907-004	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
0406-9202-30	EA - Each	0406-9202	578c3e36-ba06-4990-8e1c-99b6f7cd1c07	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL CITRATE	ACTIVE INGREDIENT	MUN5LYG46H	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	FENTANYL CITRATE (FENTANYL CITRATE ) LOZENGE [MALLINCKRODT INC.]	11

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
0406-9202-30	00406920230	30 BLISTER PACK in 1 CARTON (0406-9202-30) > 1 LOZENGE in 1 BLISTER PACK	30 blister pack	2009-10-30	0000-00-00	No	No	Current