Prescription drug · ANDA
Methotrexate NDC 0703-3675
Methotrexate sodium 25 mg/mL · Injection, Solution · Intra-arterial, Intramuscular, Intrathecal, Intravenous · Teva Parenteral Medicines, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0703-3675-01 | 00703367501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3675-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 1, 2012 |
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 — 25 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intra-arterial, Intramuscular, Intrathecal, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040843
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 0703-3675_e81074cc-12b4-4ac9-a5bb-749188989b2cSPL ID e81074cc-12b4-4ac9-a5bb-749188989b2cSPL set ID 346ec9ce-dc98-4a55-b55e-d3af11f2d703RxCUI 1655956, 1655959, 1655960UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400703367501followed by a unit qualifier and the quantityPackage 00703-3675-01. 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 Injection is a folate analog metabolic inhibitor indicated for: The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. ( 1.1 ) Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. ( 1.2 ) Treatment of adult and pediatric patients with non-Hodgkin lymphoma. ( 1.3 ) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. ( 1.4 ) Treatment of adults with breast cancer as part of a combination chemotherapy regimen. ( 1.5 ) Treatment of adults with squamous cell carcinoma of the head and neck as…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040843
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntra-arterial, Intramuscular, Intrathecal, Intravenous | Teva Parenteral Medicines, Inc. | 0703-3678 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntra-arterial, Intramuscular, Intrathecal, Intravenous | Teva Parenteral Medicines, Inc. | 0703-3671 |