What is NDC 46708-436?

46708-436 is the product NDC for Leflunomide, Leflunomide 10 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Leflunomide?

36 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Leflunomide NDC 46708-436 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-436Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0436Add 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
46708-436-30	46708043630	30 TABLET in 1 BOTTLE (46708-436-30)Marketed from Dec 1, 2016
46708-436-31	46708043631	100 TABLET in 1 BOTTLE (46708-436-31)Marketed from Dec 1, 2016
46708-436-60	46708043660	60 TABLET in 1 BOTTLE (46708-436-60)Marketed from Dec 1, 2016
46708-436-71	46708043671	500 TABLET in 1 BOTTLE (46708-436-71)Marketed from Dec 1, 2016

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): Leflunomide
Generic name (nonproprietary): leflunomide
Active ingredients: Leflunomide — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091369
Marketing start: Dec 1, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 46708-436_aa5c1860-7668-433b-bc17-c6de2b772e0fSPL ID aa5c1860-7668-433b-bc17-c6de2b772e0fSPL set ID f6a4107e-b393-45ed-8e5a-70af5bd53826RxCUI 205284, 205285UNII G162GK9U4WUPC 0346708436308, 0346708437305
Pharmacologic class: Antirheumatic Agent

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

N446708043630 followed by a unit qualifier and the quantity

Package 46708-0436-30. 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 30, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-436

What is NDC 46708-436?: 46708-436 is the product NDC for Leflunomide, Leflunomide 10 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Leflunomide.
What is the active ingredient?: Leflunomide.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leflunomide?: 36 other product NDCs are listed under this name. See all Leflunomide 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 Leflunomide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Leflunomide	Leflunomide 10 mg/1	Tablet, Film coatedOral	Burel Pharmaceuticals, LLC	35573-447	35573-0447-30
Leflunomide	Leflunomide 20 mg/1	Tablet, Film coatedOral	Burel Pharmaceuticals, LLC	35573-448	35573-0448-30
Leflunomide	Leflunomide 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5992	50090-5992-00
Leflunomide	Leflunomide 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-348	59651-0348-30
Leflunomide	Leflunomide 20 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-349	59651-0349-30
Leflunomide	Leflunomide 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-9728	63629-9728-01
Leflunomide	Leflunomide 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2256	71335-2256-0171335-2256-02
Leflunomide	Leflunomide 10 mg/1	TabletOral	AvPAK	50268-477	50268-0477-15
Leflunomide	Leflunomide 20 mg/1	TabletOral	AvPAK	50268-478	50268-0478-15
Leflunomide	Leflunomide 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3763	68071-3763-09

All 37 Leflunomide NDCs

Other NDCs under ANDA 091369

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

FDA NDC Directory listings under ANDA 091369
Product	Strength	Form · route	Labeler	Product NDC
Leflunomide	Leflunomide 20 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-437
Leflunomide	Leflunomide 10 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-061
Leflunomide	Leflunomide 20 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-062