NDC codes

FDA NDC Directory
Product NDC (as listed)82249-112Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82249-0112Add 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
82249-112-30822490112308224901123030 TABLET, FILM COATED in 1 BOTTLE (82249-112-30)Marketed from Oct 26, 2026

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
Civica Script LLCNDC labeler code 82249
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209598
Marketing start
Listing expires
Other FDA classes
Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
Identifiers
Product ID 82249-112_5e7f1c5f-435f-edeb-e063-6294a90a03dbSPL ID 5e7f1c5f-435f-edeb-e063-6294a90a03dbSPL set ID bb9b9381-dc5a-4d90-a54e-5f08a03d3796RxCUI 1310525, 1310533UNII 1C058IKG3BUPC 0382249112301, 0382249111304
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

N482249011230 followed by a unit qualifier and the quantity

Package 82249-0112-30. 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 . 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 tablet 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 82249-112

What is NDC 82249-112?
82249-112 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, film coated, listed with the FDA by Civica Script LLC. 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?
Civica Script LLC, NDC labeler code 82249. 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?
33 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 7 mg/1Tablet, Film coatedOralCivica Script LLC82249-11182249-0111-30
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralCONCORD BIOTECH LIMITED68254-501368254-5013-01
TeriflunomideTeriflunomide 14 mg/141Tablet, Film coatedOralCONCORD BIOTECH LIMITED68254-501068254-5010-01
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 14 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-01870377-0018-1170377-0018-91
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-01770377-0017-1170377-0017-91
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-24631722-0246-30

All 34 Teriflunomide NDCs

Other NDCs under ANDA 209598

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

FDA NDC Directory listings under ANDA 209598
ProductStrengthForm · routeLabelerProduct NDC
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-246
TeriflunomideTeriflunomide 14 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-247

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