What is NDC 70771-1011?

70771-1011 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. 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 70771-1011 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1011Add 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
70771-1011-3	70771101103	30 TABLET, FILM COATED in 1 BOTTLE (70771-1011-3)Marketed from Feb 14, 2023
70771-1011-8	70771101108	2 CARTON in 1 CARTON (70771-1011-8) / 1 BLISTER PACK in 1 CARTON (70771-1011-7) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 14, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209668
Marketing start: Feb 14, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
Identifiers: Product ID 70771-1011_b7b4c7bb-e9d3-4441-a7d5-b949b1656e36SPL ID b7b4c7bb-e9d3-4441-a7d5-b949b1656e36SPL set ID 58991a51-d40e-476f-8f5f-ac89e68e7107RxCUI 1310525, 1310533UNII 1C058IKG3BUPC 0370710111533
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

N470771101103 followed by a unit qualifier and the quantity

Package 70771-1011-03. 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 Aug 12, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1011

What is NDC 70771-1011?: 70771-1011 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 2 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?: Zydus Lifesciences Limited, NDC labeler code 70771. 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 14 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3156	00480-3156-56
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3157	00480-3157-56
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 209668

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

FDA NDC Directory listings under ANDA 209668
Product	Strength	Form · route	Labeler	Product NDC
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1114
Teriflunomide	Teriflunomide 14 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1115
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1010