Fentanyl Buccal

Product NDC
51862-634
11-digit product format
518620634
Labeler code
51862
Product ID
51862-634_946972d3-b88b-4b7a-9d52-5010b846b6cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate
Dosage form
TABLET
Route
BUCCAL; SUBLINGUAL
Labeler
Mayne Pharma
Application
NDA021947
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-06-14
Marketing end
0000-00-00
Substance
FENTANYL CITRATE
Active strength
100 ug/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51862-634DDiscontinued by firm2026-08-07
excluded packagepackage51862-63451862-634-28DDiscontinued 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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51862-634-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-634-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51862-634-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51862-634-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51862-634-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51862-634-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51862-634-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51862-634-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51862-634-280efc9e666f02…f202fb6c5f17…

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
N021947-001FENTORAFENTANYL CITRATEEQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2006-09-25
N021947-002FENTORAFENTANYL CITRATEEQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2006-09-25
N021947-003FENTORAFENTANYL CITRATEEQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2006-09-25
N021947-004FENTORAFENTANYL CITRATEEQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2006-09-25
N021947-005FENTORAFENTANYL CITRATEEQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2006-09-25
N021947-006FENTORAFENTANYL CITRATEEQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2007-03-02

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021947-00178628322028-06-15Drug product2011-04-25
N021947-00178628332028-06-15Drug product2011-04-25
N021947-00278628322028-06-15Drug product
N021947-00278628332028-06-15Drug product
N021947-00378628322028-06-15Drug product
N021947-00378628332028-06-15Drug product
N021947-00478628322028-06-15Drug product
N021947-00478628332028-06-15Drug product
N021947-00578628322028-06-15Drug product2011-04-25
N021947-00578628332028-06-15Drug product2011-04-25

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 UTC2026-02N021947-001FENTORAEQ 0.1MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-002FENTORAEQ 0.2MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-003FENTORAEQ 0.4MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-004FENTORAEQ 0.6MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-005FENTORAEQ 0.8MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-006FENTORAEQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2007-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-001FENTORAEQ 0.1MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-002FENTORAEQ 0.2MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-003FENTORAEQ 0.4MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-004FENTORAEQ 0.6MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-005FENTORAEQ 0.8MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-006FENTORAEQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2007-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021947-001FENTORAEQ 0.1MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-002FENTORAEQ 0.2MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-003FENTORAEQ 0.4MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-004FENTORAEQ 0.6MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-005FENTORAEQ 0.8MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-006FENTORAEQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2007-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-001FENTORAEQ 0.1MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-002FENTORAEQ 0.2MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-003FENTORAEQ 0.4MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-004FENTORAEQ 0.6MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-005FENTORAEQ 0.8MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-006FENTORAEQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2007-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021947-001FENTORAEQ 0.1MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021947-002FENTORAEQ 0.2MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021947-003FENTORAEQ 0.4MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021947-004FENTORAEQ 0.6MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021947-005FENTORAEQ 0.8MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021947-006FENTORAEQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2007-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021947-001FENTORAEQ 0.1MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021947-002FENTORAEQ 0.2MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021947-003FENTORAEQ 0.4MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021947-004FENTORAEQ 0.6MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021947-005FENTORAEQ 0.8MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021947-006FENTORAEQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / BUCCAL, SUBLINGUALRLD2007-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021947-001FENTORAEQ 0.1MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021947-002FENTORAEQ 0.2MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021947-003FENTORAEQ 0.4MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021947-004FENTORAEQ 0.6MG BASETABLET / BUCCAL, SUBLINGUALRLD2006-09-252680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-10-28 04:53 UTC2022-10N021947-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021947-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021947-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021947-004AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021947-005AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021947-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N021947-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N021947-003AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N021947-004AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N021947-005AB1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 21 · 833 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021947-00178628322028-06-15Drug product2011-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-00178628332028-06-15Drug product2011-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-00278628322028-06-15Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-00278628332028-06-15Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-00378628322028-06-15Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-00378628332028-06-15Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-00478628322028-06-15Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-00478628332028-06-15Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-00578628322028-06-15Drug product2011-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021947-00578628332028-06-15Drug product2011-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00178628322028-06-15Drug product2011-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00178628332028-06-15Drug product2011-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00278628322028-06-15Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00278628332028-06-15Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00378628322028-06-15Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00378628332028-06-15Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00478628322028-06-15Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00478628332028-06-15Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00578628322028-06-15Drug product2011-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021947-00578628332028-06-15Drug product2011-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021947-00178628322028-06-15Drug product2011-04-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-00178628332028-06-15Drug product2011-04-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-00278628322028-06-15Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-00278628332028-06-15Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-00378628322028-06-15Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-00378628332028-06-15Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-00478628322028-06-15Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-00478628332028-06-15Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-00578628322028-06-15Drug product2011-04-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021947-00578628332028-06-15Drug product2011-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00178628322028-06-15Drug product2011-04-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00178628332028-06-15Drug product2011-04-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00278628322028-06-15Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00278628332028-06-15Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00378628322028-06-15Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00378628332028-06-15Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00478628322028-06-15Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00478628332028-06-15Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00578628322028-06-15Drug product2011-04-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021947-00578628332028-06-15Drug product2011-04-25fd3edfee7708…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-634-01EA - Each51862-6341770c31b-1acf-4181-90f9-2a147250b14b12019-07-02
51862-634-28EA - Each51862-6347d700f17-9240-4019-abd7-cfa1f1b7c35512019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-634FENTANYL BUCCAL (FENTANYL CITRATE) TABLET [MAYNE PHARMA]11Legacy NDC20240222_918d0e2a-3af3-46e8-ad06-528263e03ba0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-634-285186206342828 BLISTER PACK in 1 CARTON (51862-634-28) > 1 TABLET in 1 BLISTER PACK (51862-634-01) 28 blister pack2019-06-140000-00-00NoNoCurrent