What is NDC 69339-170?

69339-170 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, listed with the FDA by Natco Pharma USA LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Natco Pharma USA LLC, NDC labeler code 69339. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Teriflunomide NDC 69339-170 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69339-170Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69339-0170Add 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
69339-170-03	6933901700369339017003	30 TABLET in 1 BOTTLE (69339-170-03)Marketed from Jan 2, 2024
69339-170-09	6933901700969339017009	90 TABLET in 1 BOTTLE (69339-170-09)Marketed from Jan 2, 2024
69339-170-93	6933901709369339017093	2 BLISTER PACK in 1 CARTON (69339-170-93) / 30 TABLET in 1 BLISTER PACKMarketed from Jun 17, 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
Route: Oral
Labeler: Natco Pharma USA LLCNDC labeler code 69339
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209555
Marketing start: Jun 17, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
Identifiers: Product ID 69339-170_70bc9344-abbf-4aca-96c0-7f10cfe9aae4SPL ID 70bc9344-abbf-4aca-96c0-7f10cfe9aae4SPL set ID 8219b4a2-fb9d-4387-ba33-96d28aad71ddRxCUI 1310525, 1310533UNII 1C058IKG3BUPC 0369339170090, 0369339169032, 0369339169094
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

N469339017003 followed by a unit qualifier and the quantity

Package 69339-0170-03. 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 2, 2024. 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)

About NDC 69339-170

What is NDC 69339-170?: 69339-170 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, listed with the FDA by Natco Pharma USA LLC. It has 3 package NDCs, 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?: Natco Pharma USA LLC, NDC labeler code 69339. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Civica Script LLC	82249-111	82249-0111-30
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	Civica Script LLC	82249-112	82249-0112-30
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	CONCORD BIOTECH LIMITED	68254-5013	68254-5013-01
Teriflunomide	Teriflunomide 14 mg/141	Tablet, Film coatedOral	CONCORD BIOTECH LIMITED	68254-5010	68254-5010-01
Teriflunomide	Teriflunomide 7 mg/1	TabletOral	Natco Pharma USA LLC	69339-169	69339-0169-0369339-0169-0969339-0169-93
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	AvKARE	42291-830	42291-0830-30
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	AvKARE	42291-831	42291-0831-30
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc.	70377-018	70377-0018-1170377-0018-91
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc.	70377-017	70377-0017-1170377-0017-91
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-246	31722-0246-30

All 34 Teriflunomide NDCs

Other NDCs under ANDA 209555

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

FDA NDC Directory listings under ANDA 209555
Product	Strength	Form · route	Labeler	Product NDC
Teriflunomide	Teriflunomide 7 mg/1	TabletOral	Natco Pharma USA LLC	69339-169