NDC codes

FDA NDC Directory
Product NDC (as listed)62135-793Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0793Add 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
62135-793-306213507933030 TABLET in 1 BOTTLE (62135-793-30)Marketed from Oct 26, 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)
Leflunomide
Generic name (nonproprietary)
leflunomide
Active ingredients
Leflunomide — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077086
Marketing start
Listing expires
Identifiers
Product ID 62135-793_46268884-f963-f34a-e063-6294a90aa8d5SPL ID 46268884-f963-f34a-e063-6294a90aa8d5SPL set ID 006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc1RxCUI 205284, 205285UNII G162GK9U4WUPC 0362135793302, 0362135794309
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

N462135079330 followed by a unit qualifier and the quantity

Package 62135-0793-30. 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 . 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 tablets are 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 62135-793

What is NDC 62135-793?
62135-793 is the product NDC for Leflunomide, Leflunomide 10 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. 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?
Chartwell RX, LLC, NDC labeler code 62135. 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 10 mg/1Tablet, Film coatedOralBurel Pharmaceuticals, LLC35573-44735573-0447-30
LeflunomideLeflunomide 20 mg/1Tablet, Film coatedOralBurel Pharmaceuticals, LLC35573-44835573-0448-30
LeflunomideLeflunomide 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-599250090-5992-00
LeflunomideLeflunomide 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-34859651-0348-30
LeflunomideLeflunomide 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-34959651-0349-30
LeflunomideLeflunomide 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-972863629-9728-01
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 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-376368071-3763-09

All 37 Leflunomide NDCs

Other NDCs under ANDA 077086

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

FDA NDC Directory listings under ANDA 077086
ProductStrengthForm · routeLabelerProduct NDC
leflunomideLeflunomide 10 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-043
leflunomideLeflunomide 20 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-044
LeflunomideLeflunomide 20 mg/1TabletOralChartwell RX, LLC62135-794
leflunomideLeflunomide 20 mg/1TabletOralBryant Ranch Prepack71335-2832
leflunomideLeflunomide 10 mg/1TabletOralBryant Ranch Prepack71335-2874
leflunomideLeflunomide 10 mg/1TabletOralBryant Ranch Prepack72162-2409
leflunomideLeflunomide 20 mg/1TabletOralBryant Ranch Prepack72162-2410

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