NDC codes

FDA NDC Directory
Product NDC (as listed)62332-314Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0314Add 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
62332-314-14623320314142 BLISTER PACK in 1 CARTON (62332-314-14) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 25, 2023
62332-314-306233203143030 TABLET, FILM COATED in 1 BOTTLE (62332-314-30)Marketed from Jan 25, 2023
62332-314-91623320314911000 TABLET, FILM COATED in 1 BOTTLE (62332-314-91)Marketed from Jan 25, 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
Teriflunomide14 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209572
Marketing start
Listing expires
Other FDA classes
Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
Identifiers
Product ID 62332-314_95e1ed70-9c5b-4bad-a26e-b33cd3f9b7eeSPL ID 95e1ed70-9c5b-4bad-a26e-b33cd3f9b7eeSPL set ID 8c1bc23b-a62b-4172-a603-8b97761514b4RxCUI 1310525, 1310533UNII 1C058IKG3BUPC 0362332313303, 0362332314300
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

N462332031414 followed by a unit qualifier and the quantity

Package 62332-0314-14. 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)

Other NDCs under ANDA 209572

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

FDA NDC Directory listings under ANDA 209572
ProductStrengthForm · routeLabelerProduct NDC
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-313
TeriflunomideTeriflunomide 14 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-314
TeriflunomideTeriflunomide 7 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-313

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