Methotrexate NDC 55150-513

NDC codes

FDA NDC Directory

Product NDC (as listed)55150-513Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55150-0513Add 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
55150-513-01	55150051301	1 VIAL in 1 CARTON (55150-513-01) / 10 mL in 1 VIALMarketed from Sep 11, 2024

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 sodium — 250 mg/10mL
Dosage form: Injection, Solution
Route: Intramuscular, Intrathecal, Intravenous, Subcutaneous
Labeler: Eugia US LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201529
Marketing start: Sep 11, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 55150-513_adc6f7e8-b3a3-476a-9939-0c5cbda63dbdSPL ID adc6f7e8-b3a3-476a-9939-0c5cbda63dbdSPL set ID 63bb6fbf-dd59-4edc-af8f-d0c397ca1262RxCUI 1655959, 1655960, 1655967, 1655968UNII 3IG1E710ZNUPC 0355150510016, 0355150510054, 0355150511013
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N455150051301 followed by a unit qualifier and the quantity

Package 55150-0513-01. 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 Jul 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methotrexate Injection is a folate analog metabolic inhibitor indicated for: The following neoplastic diseases for the: ◦ Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. ( 1.1 ) ◦ Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. ( 1.2 ) ◦ Treatment of adult and pediatric patients with non-Hodgkin lymphoma. ( 1.3 ) ◦ Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. ( 1.4 ) ◦ Treatment of adults with breast cancer as part of a combination chemotherapy regimen. ( 1.5 ) ◦ Treatment of adults with squamous cell carcinoma of the head…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201529

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

FDA NDC Directory listings under ANDA 201529
Product	Strength	Form · route	Labeler	Product NDC
Methotrexate	Methotrexate sodium 100 mg/4mL	Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous	Eugia US LLC	55150-511
Methotrexate	Methotrexate sodium 50 mg/2mL	Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous	Eugia US LLC	55150-510
Methotrexate	Methotrexate sodium 200 mg/8mL	Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous	Eugia US LLC	55150-512