What is NDC 42291-831?

42291-831 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Teriflunomide?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Teriflunomide NDC 42291-831 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-831Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0831Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42291-831-30	42291083130	30 TABLET, FILM COATED in 1 BOTTLE (42291-831-30)Marketed from Apr 20, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Teriflunomide
Generic name (nonproprietary): teriflunomide
Active ingredients: Teriflunomide — 14 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209700
Marketing start: Apr 20, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
Identifiers: Product ID 42291-831_4875c75e-d6b3-05a5-e063-6394a90aa62fSPL ID 4875c75e-d6b3-05a5-e063-6394a90aa62fSPL set ID f9c95ed7-130f-9455-e053-6394a90a182fRxCUI 1310525, 1310533UNII 1C058IKG3BUPC 0342291830301, 0342291831308
Pharmacologic class: Pyrimidine Synthesis Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442291083130 followed by a unit qualifier and the quantity

Package 42291-0831-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-831

What is NDC 42291-831?: 42291-831 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Teriflunomide.
What is the active ingredient?: Teriflunomide.
Who is the labeler?: AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Teriflunomide?: 31 other product NDCs are listed under this name. See all Teriflunomide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Teriflunomide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Teriflunomide	Teriflunomide 14 mg/141	Tablet, Film coatedOral	CONCORD BIOTECH LIMITED	68254-5010	68254-5010-01
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	CONCORD BIOTECH LIMITED	68254-5013	68254-5013-01
Teriflunomide	Teriflunomide 7 mg/1	TabletOral	Natco Pharma USA LLC	69339-169	69339-0169-0369339-0169-0969339-0169-93
Teriflunomide	Teriflunomide 14 mg/1	TabletOral	Natco Pharma USA LLC	69339-170	69339-0170-0369339-0170-0969339-0170-93
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	AvKARE	42291-830	42291-0830-30
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc.	70377-017	70377-0017-1170377-0017-91
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc.	70377-018	70377-0018-1170377-0018-91
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-400	16729-0400-10
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3156	00480-3156-56
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-399	16729-0399-10

All 32 Teriflunomide NDCs

Other NDCs under ANDA 209700

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209700
Product	Strength	Form · route	Labeler	Product NDC
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	AvKARE	42291-830
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3156
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3157