What is NDC 70377-018?

70377-018 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, film coated, listed with the FDA by Biocon Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Biocon Pharma Inc., NDC labeler code 70377. 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 70377-018 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70377-018Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70377-0018Add 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
70377-018-11	7037700181170377001811	30 TABLET, FILM COATED in 1 BOTTLE (70377-018-11)Marketed from Mar 13, 2023
70377-018-91	7037700189170377001891	2 BLISTER PACK in 1 CARTON (70377-018-91) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 13, 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, Film coated
Route: Oral
Labeler: Biocon Pharma Inc.NDC labeler code 70377
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209639
Marketing start: Mar 13, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
Identifiers: Product ID 70377-018_bc87e96a-ce9e-58b8-883a-6c9166987103SPL ID bc87e96a-ce9e-58b8-883a-6c9166987103
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

N470377001811 followed by a unit qualifier and the quantity

Package 70377-0018-11. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70377-018

What is NDC 70377-018?: 70377-018 is the product NDC for Teriflunomide, Teriflunomide 14 mg/1 tablet, film coated, listed with the FDA by Biocon Pharma Inc.. 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?: Biocon Pharma Inc., NDC labeler code 70377. 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 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 7 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-246	31722-0246-30

All 34 Teriflunomide NDCs

Other NDCs under ANDA 209639

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

FDA NDC Directory listings under ANDA 209639
Product	Strength	Form · route	Labeler	Product NDC
Teriflunomide	Teriflunomide 7 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc.	70377-017