Fentanyl Citrate

Product NDC: 0093-7868
11-digit product format: 000937868
Labeler code: 0093
Product ID: 0093-7868_4dbe9184-14cd-4666-aabf-1b7fece92337
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: 2026-08-31
Substance: FENTANYL CITRATE
Active strength: 800 ug/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Current FDA listing: Yes

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N020747-001	ACTIQ	FENTANYL CITRATE	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-002	ACTIQ	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-003	ACTIQ	FENTANYL CITRATE	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-004	ACTIQ	FENTANYL CITRATE	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-005	ACTIQ	FENTANYL CITRATE	EQ 1.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04
N020747-006	ACTIQ	FENTANYL CITRATE	EQ 1.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE / TRANSMUCOSAL	RLD	1998-11-04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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fentanyl Citrate

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENTANYL CITRATE	800 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MUN5LYG46H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310293	Internal RxNorm lookup
310294	Internal RxNorm lookup
310295	Internal RxNorm lookup
310297	Internal RxNorm lookup
313992	Internal RxNorm lookup
313993	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
78221eab-66fd-4cd8-9c81-af52eb83671c	Available on FDA.report

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
0093-7868-19	Fentanyl Citrate	1 in 1 BLISTER PACK	LOZENGE	1		16
0093-7868-65	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
0093-7868-19	EA - Each	0093-7868	4d3c6751-9779-43eb-9267-8d7bb2e16f8a	1	2015-12-02
0093-7868-65	EA - Each	0093-7868	6775647d-8769-4605-86cb-e45f79128a73	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
0093-7868	FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20241018_78221eab-66fd-4cd8-9c81-af52eb83671c.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 ndc (product): 0093-7868

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
0093-7868-19	00093786819	1 in 1 BLISTER PACK						Historical
0093-7868-65	00093786865	30 BLISTER PACK in 1 CARTON (0093-7868-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7868-19)	30 blister pack	2015-12-08	2026-08-31	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