Fentanyl Citrate

Product NDC: 0093-7865
11-digit product format: 000937865
Labeler code: 0093
Product ID: 0093-7865_fbd13f54-5afe-4acc-afa6-2dfa78704003
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fentanyl Citrate
Dosage form: LOZENGE
Route: ORAL; TRANSMUCOSAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: NDA020747
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-12-08
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: 2024-12-31
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	0093-7865		D	Discontinued by firm		2026-10-15
excluded package	package	0093-7865	0093-7865-65	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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N020747-001	ACTIQ	FENTANYL CITRATE	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-002	ACTIQ	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-003	ACTIQ	FENTANYL CITRATE	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-004	ACTIQ	FENTANYL CITRATE	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04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 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020747-001	ACTIQ	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020747-002	ACTIQ	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020747-003	ACTIQ	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020747-004	ACTIQ	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020747-005	ACTIQ	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020747-006	ACTIQ	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	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020747-001	ACTIQ	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020747-002	ACTIQ	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020747-003	ACTIQ	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020747-004	ACTIQ	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020747-005	ACTIQ	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020747-006	ACTIQ	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020747-001	ACTIQ	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020747-002	ACTIQ	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020747-003	ACTIQ	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020747-004	ACTIQ	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020747-005	ACTIQ	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020747-006	ACTIQ	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	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020747-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020747-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020747-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020747-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020747-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020747-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020747-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020747-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020747-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020747-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020747-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020747-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020747-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020747-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020747-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020747-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020747-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020747-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020747-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020747-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020747-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020747-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020747-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020747-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020747-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020747-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020747-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020747-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020747-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020747-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020747-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020747-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020747-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020747-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020747-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020747-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020747-006	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020747-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020747-002	AB	1	`a67488948f0b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-7865-19	Fentanyl Citrate	1 in 1 BLISTER PACK	LOZENGE	1		16
0093-7865-65	Fentanyl Citrate	30 in 1 CARTON	LOZENGE	30		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7865-19	EA - Each	0093-7865	167fb4ff-f7f3-4fa7-9cae-dca38b3602d3	1	2015-12-02
0093-7865-65	EA - Each	0093-7865	76aa8ab8-e9a9-4f34-960c-22261c534e1d	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL CITRATE	ACTIVE INGREDIENT	MUN5LYG46H	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]	1
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]	1
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]	1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]	1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-7865	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA, INC.]	15	Legacy NDC, 2 package rows	20241018_78221eab-66fd-4cd8-9c81-af52eb83671c.zip

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	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310294	fentaNYL citrate 1600 MCG Oral Lozenge	PSN	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310295	fentaNYL citrate 200 MCG Oral Lozenge	PSN	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310297	fentaNYL citrate 400 MCG Oral Lozenge	PSN	78221eab-66fd-4cd8-9c81-af52eb83671c	16
313992	fentaNYL citrate 600 MCG Oral Lozenge	PSN	78221eab-66fd-4cd8-9c81-af52eb83671c	16
313993	fentaNYL citrate 800 MCG Oral Lozenge	PSN	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310295	fentanyl 0.2 MG Oral Lozenge	SCD	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310297	fentanyl 0.4 MG Oral Lozenge	SCD	78221eab-66fd-4cd8-9c81-af52eb83671c	16
313992	fentanyl 0.6 MG Oral Lozenge	SCD	78221eab-66fd-4cd8-9c81-af52eb83671c	16
313993	fentanyl 0.8 MG Oral Lozenge	SCD	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310293	fentanyl 1.2 MG Oral Lozenge	SCD	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310294	fentanyl 1.6 MG Oral Lozenge	SCD	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310293	fentanyl (as fentanyl citrate) 1200 MCG Oral Lozenge	SY	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310294	fentanyl (as fentanyl citrate) 1600 MCG Oral Lozenge	SY	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310295	fentanyl (as fentanyl citrate) 200 MCG Oral Lozenge	SY	78221eab-66fd-4cd8-9c81-af52eb83671c	16
310297	fentanyl (as fentanyl citrate) 400 MCG Oral Lozenge	SY	78221eab-66fd-4cd8-9c81-af52eb83671c	16
313992	fentanyl (as fentanyl citrate) 600 MCG Oral Lozenge	SY	78221eab-66fd-4cd8-9c81-af52eb83671c	16
313993	fentanyl (as fentanyl citrate) 800 MCG Oral Lozenge	SY	78221eab-66fd-4cd8-9c81-af52eb83671c	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-7865-19	00093786519	1 in 1 BLISTER PACK						Historical
0093-7865-65	00093786565	30 BLISTER PACK in 1 CARTON (0093-7865-65) > 1 LOZENGE in 1 BLISTER PACK (0093-7865-19)	30 blister pack	2015-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fentanyl Citrate - Teva Pharmaceuticals USA, Inc.	Teva Pharmaceuticals USA, Inc.	2026-01-31	HUMAN PRESCRIPTION DRUG LABEL	16