Fentanyl Citrate

Product NDC
0093-7867
Requested package NDC
0093-7867-65
11-digit product format
000937867
Labeler code
0093
Product ID
0093-7867_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
600 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0093-78670093-7867-65DDiscontinued by firm2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-78670093-7867-65DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-78670093-7867-65DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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-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N020747-001ACTIQFENTANYL CITRATEEQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020747-005ACTIQEQ 1.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020747-006ACTIQEQ 1.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020747-001ACTIQEQ 0.2MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020747-002ACTIQEQ 0.4MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020747-003ACTIQEQ 0.6MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020747-004ACTIQEQ 0.8MG BASETROCHE/LOZENGE / TRANSMUCOSALRLD1998-11-042680178bc6a6…

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
0093-7867-19Fentanyl Citrate1 in 1 BLISTER PACKLOZENGE116
0093-7867-65Fentanyl Citrate30 in 1 CARTONLOZENGE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7867-19EA - Each0093-78679b6196ce-587c-4237-aa5a-f312c9233bd612015-12-02
0093-7867-65EA - Each0093-78672c798f47-5264-4757-af82-dc368f0b32bb12015-12-02

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
0093-7867FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA, INC.]15Legacy NDC, 2 package rows20241018_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fentanyl CitrateFENTANYL CITRATETeva Pharmaceuticals USA, Inc.78221eab-66fd-4cd8-9c81-af52eb83671c2026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020747
application number: NDA020747
ndc (package): 0093-7867-65
ndc (product): 0093-7867
ndc11 (package): 00093786765

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
0093-7867-650009378676530 BLISTER PACK in 1 CARTON (0093-7867-65) > 1 LOZENGE in 1 BLISTER PACK (0093-7867-19) 30 blister pack2015-12-080000-00-00NoNoCurrent