Teriflunomide

Product NDC: 0115-1565
11-digit product format: 001151565
Labeler code: 0115
Product ID: 0115-1565_ed5b2e8a-3ef9-44c2-ba77-b75abbd811e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Teriflunomide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA209677
Marketing category: ANDA
Marketing start: 2020-06-17
Marketing end: 0000-00-00
Substance: TERIFLUNOMIDE
Active strength: 14 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0115-1565		D	Discontinued by firm		2026-08-07
excluded package	package	0115-1565	0115-1565-44	D	Discontinued by firm		2026-08-07

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-1565-44	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-1565-44	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-1565-44	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-1565-44	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-1565-44	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-1565-44	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-1565-44	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-1565-44	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-1565-44	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-1565-44	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-1565-44	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-1565-44	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0115-1565-44	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0115-1565-44	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0115-1565-44	`1332a3947898…`	`d4bfe170f9cd…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209677-001	TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB		2020-06-17
A209677-002	TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB		2023-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209677-001	AB
A209677-002	AB

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 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL		2020-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL		2020-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL		2020-06-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL		2020-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL		2020-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL		2020-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209677-002	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2023-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209677-001	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2020-06-17	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209677-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209677-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209677-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209677-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209677-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209677-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209677-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209677-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209677-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209677-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209677-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209677-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209677-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209677-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209677-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209677-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209677-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209677-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209677-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209677-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209677-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209677-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209677-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209677-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209677-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209677-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209677-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209677-002	AB	1	`8072bd15b7f6…`
2021-03-12 10:30 UTC	2021-03	A209677-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209677-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209677-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209677-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209677-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209677-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209677-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209677-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209677-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209677-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209677-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209677-001	AB	1	`9b2671bbb829…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0115-1565-44	2025-12-12	C162847	48780-1	f386c64a-2cdf-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TERIFLUNOMIDE TABLETS safely and effectively. See full prescribing information for TERIFLUNOMIDE TABLETS. TERIFLUNOMIDE tablets, for oral use Initial U.S. Approval: 2012
0115-1565-44	2023-01-30	C162847	48780-1	f386c64a-2cdf-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TERIFLUNOMIDE TABLETS safely and effectively. See full prescribing information for TERIFLUNOMIDE TABLETS. TERIFLUNOMIDE tablets, for oral use Initial U.S. Approval: 2012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1565	TERIFLUNOMIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	1	Legacy NDC	20200619_57a0226d-74a3-4753-8683-ddc86dade0ae.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1C058IKG3B	TERIFLUNOMIDE	163451-81-8	TERIFLUNOMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1565-44	00115156544	28 TABLET, FILM COATED in 1 CARTON (0115-1565-44)	2020-06-17	0000-00-00	No	No	Current