What is NDC 69539-315?

69539-315 is the product NDC for Teriflunomide, Teriflunomide 7 mg/1 tablet, film coated, listed with the FDA by MSN LABORATORIES PRIVATE LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.

MSN LABORATORIES PRIVATE LIMITED, NDC labeler code 69539. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Teriflunomide NDC 69539-315 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69539-315Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69539-0315Add 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
69539-315-41	69539031541	2 BLISTER PACK in 1 CARTON (69539-315-41) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 24, 2019

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 — 7 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: MSN LABORATORIES PRIVATE LIMITEDNDC labeler code 69539
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209623
Marketing start: Apr 24, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
Identifiers: Product ID 69539-315_3b178225-b3ba-4c9f-bde6-a5e076697980SPL ID 3b178225-b3ba-4c9f-bde6-a5e076697980SPL set ID 63ba28ef-5055-461a-99ef-c49e8ece4b54RxCUI 1310525, 1310533UNII 1C058IKG3BUPC 0369539033416, 0369539033300, 0369539032419
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

N469539031541 followed by a unit qualifier and the quantity

Package 69539-0315-41. 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 Feb 3, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Teriflunomide tablet is 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 69539-315

What is NDC 69539-315?: 69539-315 is the product NDC for Teriflunomide, Teriflunomide 7 mg/1 tablet, film coated, listed with the FDA by MSN LABORATORIES PRIVATE LIMITED. 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?: MSN LABORATORIES PRIVATE LIMITED, NDC labeler code 69539. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Teriflunomide	Teriflunomide 14 mg/141	Tablet, Film coatedOral	CONCORD BIOTECH LIMITED	68254-5010	68254-5010-01
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	CONCORD BIOTECH LIMITED	68254-5013	68254-5013-01
Teriflunomide	Teriflunomide 7 mg/1	TabletOral	Natco Pharma USA LLC	69339-169	69339-0169-0369339-0169-0969339-0169-93
Teriflunomide	Teriflunomide 14 mg/1	TabletOral	Natco Pharma USA LLC	69339-170	69339-0170-0369339-0170-0969339-0170-93
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 7 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc.	70377-017	70377-0017-1170377-0017-91
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	Accord Healthcare Inc.	16729-399	16729-0399-10
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-400	16729-0400-10

All 32 Teriflunomide NDCs

Other NDCs under ANDA 209623

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

FDA NDC Directory listings under ANDA 209623
Product	Strength	Form · route	Labeler	Product NDC
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	MSN LABORATORIES PRIVATE LIMITED	69539-032
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	MSN LABORATORIES PRIVATE LIMITED	69539-033
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	MSN LABORATORIES PRIVATE LIMITED	69539-316