TERIFLUNOMIDE

Product NDC: 68254-5009
11-digit product format: 682545009
Labeler code: 68254
Product ID: 68254-5009_ebb5a19c-6889-4d12-b9fd-b7dea06a52d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TERIFLUNOMIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CONCORD BIOTECH LIMITED
Application: ANDA218663
Marketing category: ANDA
Marketing start: 2025-07-07
Substance: TERIFLUNOMIDE
Active strength: 7 mg/1
Pharmacologic classes: Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68254-5009		D	Discontinued by firm		2026-08-11
excluded package	package	68254-5009	68254-5009-1	D	Discontinued by firm		2026-08-11

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
A218663-001	TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB		2025-04-07
A218663-002	TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB		2025-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218663-001	AB
A218663-002	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.

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	A218663-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2025-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218663-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2025-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218663-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2025-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218663-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2025-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218663-001	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2025-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218663-002	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2025-04-07	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218663-001	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2025-04-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218663-002	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2025-04-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A218663-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218663-002	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218663-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218663-002	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b23dff57-5bec-bcbf-9b41-f1c0342e8e1e	Product name	7	20240514

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68254-5009-1	TERIFLUNOMIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TERIFLUNOMIDE	TERIFLUNOMIDE	CONCORD BIOTECH LIMITED	2d2724f6-8812-4a26-b2ec-936b71f868e1	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218663 application number: ANDA218663

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1310525	teriflunomide 14 MG Oral Tablet	PSN	2d2724f6-8812-4a26-b2ec-936b71f868e1	2
1310533	teriflunomide 7 MG Oral Tablet	PSN	2d2724f6-8812-4a26-b2ec-936b71f868e1	2
1310525	teriflunomide 14 MG Oral Tablet	SCD	2d2724f6-8812-4a26-b2ec-936b71f868e1	2
1310533	teriflunomide 7 MG Oral Tablet	SCD	2d2724f6-8812-4a26-b2ec-936b71f868e1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68254-5009-1	68254500901	30 TABLET, FILM COATED in 1 BOTTLE (68254-5009-1)	2025-07-07	No	No	Historical