What is NDC 0054-4550?

0054-4550 is the product NDC for Methotrexate Sodium, Methotrexate sodium 2.5 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Methotrexate Sodium?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methotrexate Sodium NDC 0054-4550 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-4550Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-4550Add 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
0054-4550-25	0005445502500054455025	100 TABLET in 1 BOTTLE, PLASTIC (0054-4550-25)Marketed from Aug 1, 1994

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 Sodium
Generic name (nonproprietary): methotrexate sodium
Active ingredients: Methotrexate sodium — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040054
Marketing start: Aug 1, 1994
Listing expires: Dec 31, 2027
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 0054-4550_09f7cdcb-241e-4916-a68c-b4c452d3d640SPL ID 09f7cdcb-241e-4916-a68c-b4c452d3d640SPL set ID d71b1856-99d8-4a9e-9189-f87b6675f80aRxCUI 105585UNII 3IG1E710ZNUPC 0300544550253
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

N400054455025 followed by a unit qualifier and the quantity

Package 00054-4550-25. 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 20, 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)

About NDC 0054-4550

What is NDC 0054-4550?: 0054-4550 is the product NDC for Methotrexate Sodium, Methotrexate sodium 2.5 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Methotrexate Sodium.
What is the active ingredient?: Methotrexate sodium.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methotrexate Sodium?: 1 other product NDC are listed under this name. See all Methotrexate Sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Methotrexate Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methotrexate Sodium	Methotrexate sodium 2.5 mg/1	TabletOral	Elite Laboratories, Inc.	64850-330	64850-0330-01