NDC codes

FDA NDC Directory
Product NDC (as listed)59651-182Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0182Add 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 NDC11-digit (billing)PackageCopy
59651-182-0159651018201100 TABLET in 1 BOTTLE (59651-182-01)Marketed from Jan 30, 2020
59651-182-365965101823636 TABLET in 1 BOTTLE (59651-182-36)Marketed from Jan 30, 2020

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 — 2.5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210454
Marketing start
Listing expires
Other FDA classes
Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers
Product ID 59651-182_9fe03573-fff3-4051-8598-8542eee1273fSPL ID 9fe03573-fff3-4051-8598-8542eee1273fSPL set ID 09931d44-a3f8-49dc-a3f2-b527ee4214bfRxCUI 105585UNII 3IG1E710ZNUPC 0359651182017, 0359651182369
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

N459651018201 followed by a unit qualifier and the quantity

Package 59651-0182-01. 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 . 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 210454

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

FDA NDC Directory listings under ANDA 210454
ProductStrengthForm · routeLabelerProduct NDC
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralChartwell RX, LLC62135-772
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralBryant Ranch Prepack71335-2221
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3765

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