Methotrexate NDC 68071-3765

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3765Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3765Add 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
68071-3765-6	68071376506	60 TABLET in 1 BOTTLE (68071-3765-6)Marketed from Jan 14, 2025
68071-3765-9	68071376509	90 TABLET in 1 BOTTLE (68071-3765-9)Marketed from Jan 10, 2025

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): Methotrexate
Generic name (nonproprietary): methotrexate
Active ingredients: Methotrexate sodium — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NuCare Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210454
Marketing start: Jan 30, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 68071-3765_2bae0372-8ccb-0028-e063-6294a90a889fSPL ID 2bae0372-8ccb-0028-e063-6294a90a889fSPL set ID 2b61822e-b488-5eaf-e063-6394a90a2dcdRxCUI 105585UNII 3IG1E710ZNUPC 0368071376593
Pharmacologic class: Folate Analog Metabolic 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

N468071376506 followed by a unit qualifier and the quantity

Package 68071-3765-06. 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 Jan 14, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis ( 1.4 ) 1.1 Neoplastic Diseases Methotrexate tablets areindicated for the: treatment of adults and pediatri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210454

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

FDA NDC Directory listings under ANDA 210454
Product	Strength	Form · route	Labeler	Product NDC
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Chartwell RX, LLC	62135-772
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-2221
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Aurobindo Pharma Limited	59651-182