NDC codes

FDA NDC Directory
Product NDC (as listed)64850-330Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64850-0330Add 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
64850-330-016485003300164850033001100 TABLET in 1 BOTTLE, PLASTIC (64850-330-01)Marketed from May 16, 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 Sodium
Generic name (nonproprietary)
methotrexate sodium
Active ingredients
Methotrexate sodium — 2.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Elite Laboratories, Inc.NDC labeler code 64850
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216453
Marketing start
Listing expires
Other FDA classes
Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers
Product ID 64850-330_030a6bcf-d482-4c98-9d27-423235cdb930SPL ID 030a6bcf-d482-4c98-9d27-423235cdb930SPL set ID 89c05ea3-3be1-46dd-b112-29c436fd7289RxCUI 105585UNII 3IG1E710ZNUPC 0364850330015
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

N464850033001 followed by a unit qualifier and the quantity

Package 64850-0330-01. 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 diydrofolate 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 adult…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64850-330

What is NDC 64850-330?
64850-330 is the product NDC for Methotrexate Sodium, Methotrexate sodium 2.5 mg/1 tablet, listed with the FDA by Elite Laboratories, 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?
Elite Laboratories, Inc., NDC labeler code 64850. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Methotrexate SodiumMethotrexate sodium 2.5 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-455000054-4550-25

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