Trexall (methotrexate) NDC 51285-366

NDC codes

FDA NDC Directory

Product NDC (as listed)51285-366Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51285-0366Add 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
51285-366-01	51285036601	30 TABLET, FILM COATED in 1 BOTTLE (51285-366-01)Marketed from May 3, 2001

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): Trexall
Generic name (nonproprietary): methotrexate
Active ingredients: Methotrexate sodium — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Teva Women's Health LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040385
Marketing start: May 3, 2001
Listing expires: Dec 31, 2027
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 51285-366_d1e7432e-253d-49f0-ab0a-bb859210ccd6SPL ID d1e7432e-253d-49f0-ab0a-bb859210ccd6SPL set ID e942f8db-510f-44d6-acb5-b822196f5e8cRxCUI 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595UNII 3IG1E710ZNUPC 0351285367013, 0351285369017
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

N451285036601 followed by a unit qualifier and the quantity

Package 51285-0366-01. 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 Jun 17, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

TREXALL is 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 TREXALL is indicated for the: treatment of adults and pediatric patients with acute lymph…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040385

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

FDA NDC Directory listings under ANDA 040385
Product	Strength	Form · route	Labeler	Product NDC
Trexallmethotrexate	Methotrexate sodium 7.5 mg/1	Tablet, Film coatedOral	Teva Women's Health LLC	51285-367
Trexallmethotrexate	Methotrexate sodium 10 mg/1	Tablet, Film coatedOral	Teva Women's Health LLC	51285-368
Trexallmethotrexate	Methotrexate sodium 15 mg/1	Tablet, Film coatedOral	Teva Women's Health LLC	51285-369