Methotrexate NDC 0378-0014

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0014Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0014Add 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
0378-0014-01	00378001401	100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01)Marketed from May 18, 1992

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 081235
Marketing start: May 18, 1992
Listing expires: Dec 31, 2027
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 0378-0014_01ad6cb9-5879-4c06-801b-0de84eebaae7SPL ID 01ad6cb9-5879-4c06-801b-0de84eebaae7SPL set ID 70c09984-2b36-424f-8b27-3fd0cd4e833dRxCUI 105585UNII 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 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

N400378001401 followed by a unit qualifier and the quantity

Package 00378-0014-01. 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 May 7, 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 adul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 081235

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

FDA NDC Directory listings under ANDA 081235
Product	Strength	Form · route	Labeler	Product NDC
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Mylan Institutional Inc.	51079-670
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-121
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-1118
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Safecor Health LLC	48433-065