Methotrexate (methotrexate sodium) NDC 63323-123

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-123Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0123Add 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
63323-123-10	63323012310	1 VIAL in 1 CARTON (63323-123-10) / 10 mL in 1 VIALMarketed from Sep 10, 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): Methotrexate
Generic name (nonproprietary): methotrexate sodium
Active ingredients: Methotrexate sodium — 25 mg/mL
Dosage form: Injection, Solution
Route: Intra-arterial, Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040263
Marketing start: Sep 10, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 63323-123_880c2caa-1b11-45ce-a54e-a3733da367f0SPL ID 880c2caa-1b11-45ce-a54e-a3733da367f0SPL set ID b585f621-f6c9-4735-ab61-bd1b401f3df0RxCUI 1946772UNII 3IG1E710ZN
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

N463323012310 followed by a unit qualifier and the quantity

Package 63323-0123-10. 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 Mar 24, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated for use in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin’s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)