Prescription drug · ANDA
Methotrexate Sodium NDC 64850-330
Methotrexate sodium 2.5 mg/1 · Tablet · Oral · Elite Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64850-330-01 | 6485003300164850033001 | 100 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
N464850033001followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Methotrexate Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methotrexate Sodium | Methotrexate sodium 2.5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-4550 | 00054-4550-25 |