NDC codes

FDA NDC Directory
Product NDC (as listed)70748-129Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70748-0129Add 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 NDC11-digit (billing)PackageCopy
70748-129-067074801290630 TABLET, FILM COATED in 1 BOTTLE (70748-129-06)Marketed from Aug 31, 2020

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, Film coated
Route
Oral
Labeler
Lupin Pharmaceuticals, Inc.NDC labeler code 70748
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211863
Marketing start
Listing expires
Identifiers
Product ID 70748-129_5d28a5cf-ca54-4fcc-a459-2be6ba1afb3eSPL ID 5d28a5cf-ca54-4fcc-a459-2be6ba1afb3eSPL set ID 5d48fded-b43b-461a-8488-ca1da5c41a03RxCUI 205284, 205285UNII G162GK9U4WUPC 0370748129067, 0370748130063
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

N470748012906 followed by a unit qualifier and the quantity

Package 70748-0129-06. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70748-129

What is NDC 70748-129?
70748-129 is the product NDC for Leflunomide, Leflunomide 10 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, 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?
Lupin Pharmaceuticals, Inc., NDC labeler code 70748. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LeflunomideLeflunomide 20 mg/1Tablet, Film coatedOralBurel Pharmaceuticals, LLC35573-44835573-0448-30
LeflunomideLeflunomide 10 mg/1Tablet, Film coatedOralBurel Pharmaceuticals, LLC35573-44735573-0447-30
LeflunomideLeflunomide 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-972863629-9728-01
LeflunomideLeflunomide 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-34959651-0349-30
LeflunomideLeflunomide 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-34859651-0348-30
LeflunomideLeflunomide 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-599250090-5992-00
LeflunomideLeflunomide 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-225671335-2256-0171335-2256-02
LeflunomideLeflunomide 10 mg/1TabletOralAvPAK50268-47750268-0477-15
LeflunomideLeflunomide 20 mg/1TabletOralAvPAK50268-47850268-0478-15
LeflunomideLeflunomide 20 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.70748-13070748-0130-06

All 37 Leflunomide NDCs

Other NDCs under ANDA 211863

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

FDA NDC Directory listings under ANDA 211863
ProductStrengthForm · routeLabelerProduct NDC
LeflunomideLeflunomide 20 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.70748-130
LeflunomideLeflunomide 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3763

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in