Prescription drug · ANDA
Methotrexate NDC 0143-9519
Methotrexate 25 mg/mL · Solution · Intra-arterial, Intramuscular, Intrathecal, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9519-10 | 00143951910 | 10 VIAL in 1 CARTON (0143-9519-10) / 2 mL in 1 VIALMarketed from Oct 10, 2017 |
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 — 25 mg/mL
- Dosage form
- Solution
- Route
- Intra-arterial, Intramuscular, Intrathecal, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089340
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 0143-9519_3046ff78-3565-46d1-a88b-283e5ff6e7c3SPL ID 3046ff78-3565-46d1-a88b-283e5ff6e7c3SPL set ID 3989d30d-56e5-4e8d-9379-c30fecc894f2RxCUI 1655959, 1655960, 1655967, 1655968UNII YL5FZ2Y5U1
- 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
N400143951910followed by a unit qualifier and the quantityPackage 00143-9519-10. 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 sing…
Excerpt only. Read the full label for complete information.