Fentanyl Citrate

Product NDC
0093-7870
Requested package NDC
0093-7870-65
11-digit product format
000937870
Labeler code
0093
Product ID
0093-7870_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
2026-05-31
Substance
FENTANYL CITRATE
Active strength
1600 ug/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0093-78700093-7870-65DDiscontinued by firm2026-09-14

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020747-001ACTIQFENTANYL CITRATEEQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-002ACTIQFENTANYL CITRATEEQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-003ACTIQFENTANYL CITRATEEQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-004ACTIQFENTANYL CITRATEEQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-005ACTIQFENTANYL CITRATEEQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04
N020747-006ACTIQFENTANYL CITRATEEQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020747-001ACTIQEQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-002ACTIQEQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-003ACTIQEQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-004ACTIQEQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-005ACTIQEQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N020747-006ACTIQEQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0484e616aacf4f…
2026-08-18 06:07:402026-07N020747-001ACTIQEQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-002ACTIQEQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-003ACTIQEQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-004ACTIQEQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-005ACTIQEQ 1.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N020747-006ACTIQEQ 1.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020747-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020747-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020747-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020747-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020747-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020747-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020747-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020747-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020747-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020747-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020747-006AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020747-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020747-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020747-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020747-004AB187673890dc5c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
a8df478d-5b88-9654-981b-87dff14dda8bProduct name220190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57Product name220180118
bb365072-425e-ca0a-021e-fd8b78162502Product name220161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6Product name220160104
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7870-19Fentanyl Citrate1 in 1 BLISTER PACKLOZENGE116
0093-7870-65Fentanyl Citrate30 in 1 CARTONLOZENGE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7870-19EA - Each0093-7870c39e62a3-2379-494f-9ae2-4623557f0a8612015-12-02
0093-7870-65EA - Each0093-7870b2ea4149-88d3-4ad5-bf6a-1a5744aff9eb12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYL CITRATEACTIVE INGREDIENTMUN5LYG46HFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
FENTANYLACTIVE MOIETYUF599785JZFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
DEXTRATESINACTIVE INGREDIENTG263MI44RUFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7870FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20241018_78221eab-66fd-4cd8-9c81-af52eb83671c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310293fentaNYL citrate 1200 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
310294fentaNYL citrate 1600 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
310295fentaNYL citrate 200 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
310297fentaNYL citrate 400 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
313992fentaNYL citrate 600 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
313993fentaNYL citrate 800 MCG Oral LozengePSN78221eab-66fd-4cd8-9c81-af52eb83671c16
310295fentanyl 0.2 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
310297fentanyl 0.4 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
313992fentanyl 0.6 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
313993fentanyl 0.8 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
310293fentanyl 1.2 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
310294fentanyl 1.6 MG Oral LozengeSCD78221eab-66fd-4cd8-9c81-af52eb83671c16
310293fentanyl (as fentanyl citrate) 1200 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
310294fentanyl (as fentanyl citrate) 1600 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
310295fentanyl (as fentanyl citrate) 200 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
310297fentanyl (as fentanyl citrate) 400 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
313992fentanyl (as fentanyl citrate) 600 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16
313993fentanyl (as fentanyl citrate) 800 MCG Oral LozengeSY78221eab-66fd-4cd8-9c81-af52eb83671c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7870-650009378706530 BLISTER PACK in 1 CARTON (0093-7870-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7870-19) 30 blister pack2015-12-082026-05-31NoNoCurrent