Teriflunomide NDC 0378-0628

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0628Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0628Add 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
0378-0628-93	00378062893	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0628-93)Marketed from Mar 31, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209702
Marketing start: Feb 14, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
Identifiers: Product ID 0378-0628_1824aae5-58af-43da-8231-435c8f118bc0SPL ID 1824aae5-58af-43da-8231-435c8f118bc0SPL set ID 1824aae5-58af-43da-8231-435c8f118bc0RxCUI 1310525, 1310533UNII 1C058IKG3B
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

N400378062893 followed by a unit qualifier and the quantity

Package 00378-0628-93. 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 Aug 24, 2022. 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 tablets are 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)

Other NDCs under ANDA 209702

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

FDA NDC Directory listings under ANDA 209702
Product	Strength	Form · route	Labeler	Product NDC
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-0627