FDA.reportPublic FDA data

Teriflunomide

Product NDC
69238-1303
11-digit product format
692381303
Labeler code
69238
Product ID
69238-1303_3cdb678e-3c0f-4331-a8d7-288741384e32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Teriflunomide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209613
Marketing category
ANDA
Marketing start
2018-10-01
Marketing end
0000-00-00
Substance
TERIFLUNOMIDE
Active strength
7 mg/1
Pharmacologic classes
Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69238-1303DDiscontinued by firm2026-08-07
excluded packagepackage69238-130369238-1303-2DDiscontinued by firm2026-08-07
excluded packagepackage69238-130369238-1303-6DDiscontinued by firm2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209613-001TERIFLUNOMIDETERIFLUNOMIDE7MGTABLET / ORAL2018-09-28
A209613-002TERIFLUNOMIDETERIFLUNOMIDE14MGTABLET / ORAL2018-09-28

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209613-001TERIFLUNOMIDE7MGTABLET / ORALAB2018-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209613-002TERIFLUNOMIDE14MGTABLET / ORALAB2018-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209613-001TERIFLUNOMIDE7MGTABLET / ORAL2018-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A209613-002TERIFLUNOMIDE14MGTABLET / ORAL2018-09-28782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A209613-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209613-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209613-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209613-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209613-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A209613-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209613-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209613-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209613-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209613-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209613-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209613-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209613-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209613-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209613-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209613-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209613-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A209613-002AB1053a50430f4f…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2023-12-20 04:57 UTC2023-12A209613-001PC2023-09-08ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209613-002PC2023-09-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209613-001PC2023-09-08a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209613-002PC2023-09-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209613-001PC2023-09-089b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209613-002PC2023-09-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209613-001PC2023-09-08a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209613-002PC2023-09-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209613-001PC2023-09-083f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209613-002PC2023-09-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A209613-001PC2023-09-08053a50430f4f…
2023-05-13 08:27 UTC2023-05A209613-002PC2023-09-08053a50430f4f…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1303-6EA - Each69238-130317b318ec-903d-4bd5-8fe1-da299fc89e0a12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1303TERIFLUNOMIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]10Legacy NDC20250221_1f054d91-aede-4c1a-9aba-04f40d11e4d1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1303-2692381303022 BLISTER PACK in 1 CARTON (69238-1303-2) > 14 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2018-10-010000-00-00NoNoCurrent
69238-1303-66923813030628 TABLET, FILM COATED in 1 BOTTLE (69238-1303-6) 2018-10-010000-00-00NoNoCurrent