Methotrexate NDC 50268-554

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-554Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0554Add 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
50268-554-15	50268055415	50 BLISTER PACK in 1 BOX (50268-554-15) / 1 TABLET in 1 BLISTER PACK (50268-554-11)Marketed from Jan 29, 2026

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): Methotrexate
Generic name (nonproprietary): methotrexate
Active ingredients: Methotrexate — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207812
Marketing start: Jan 29, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 50268-554_4992f7cb-30dc-6354-e063-6294a90a6784SPL ID 4992f7cb-30dc-6354-e063-6294a90a6784SPL set ID 4992fdaa-b880-ee25-e063-6394a90af03bRxCUI 105585UNII YL5FZ2Y5U1
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

N450268055415 followed by a unit qualifier and the quantity

Package 50268-0554-15. 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 29, 2026. 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 are indicated for the: treatment of adults and pediatr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207812

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

FDA NDC Directory listings under ANDA 207812
Product	Strength	Form · route	Labeler	Product NDC
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1058
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-775
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	Major Pharmaceuticals	0904-7141