NDC codes

FDA NDC Directory
Product NDC (as listed)0480-3156Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00480-3156Add 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 NDC11-digit (billing)PackageCopy
0480-3156-560048031565630 TABLET, FILM COATED in 1 BOTTLE (0480-3156-56)Marketed from Mar 13, 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
Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209700
Marketing start
Listing expires
Other FDA classes
Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
Identifiers
Product ID 0480-3156_ab872943-4035-4a09-afd2-3a338daf6f64SPL ID ab872943-4035-4a09-afd2-3a338daf6f64SPL set ID c424959d-00c9-4e76-aba6-cc7464d8e903RxCUI 1310525, 1310533UNII 1C058IKG3BUPC 0304803157566, 0304803156569
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

N400480315656 followed by a unit qualifier and the quantity

Package 00480-3156-56. 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 . 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 0480-3156

What is NDC 0480-3156?
0480-3156 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, Inc.. 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?
Teva Pharmaceuticals, Inc., NDC labeler code 0480. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TeriflunomideTeriflunomide 14 mg/141Tablet, Film coatedOralCONCORD BIOTECH LIMITED68254-501068254-5010-01
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralCONCORD BIOTECH LIMITED68254-501368254-5013-01
TeriflunomideTeriflunomide 7 mg/1TabletOralNatco Pharma USA LLC69339-16969339-0169-0369339-0169-0969339-0169-93
TeriflunomideTeriflunomide 14 mg/1TabletOralNatco Pharma USA LLC69339-17069339-0170-0369339-0170-0969339-0170-93
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralAvKARE42291-83042291-0830-30
TeriflunomideTeriflunomide 14 mg/1Tablet, Film coatedOralAvKARE42291-83142291-0831-30
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-01770377-0017-1170377-0017-91
TeriflunomideTeriflunomide 14 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-01870377-0018-1170377-0018-91
TeriflunomideTeriflunomide 14 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-40016729-0400-10
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-39916729-0399-10

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
ProductStrengthForm · routeLabelerProduct NDC
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralAvKARE42291-830
TeriflunomideTeriflunomide 14 mg/1Tablet, Film coatedOralAvKARE42291-831
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-3157

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