Prescription drug · ANDA
Methotrexate NDC 0143-9517
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 |
|---|---|---|---|
| 0143-9517-01 | 0014395170100143951701 | 1 VIAL in 1 BOX (0143-9517-01) / 8 mL in 1 VIALMarketed from Jan 5, 2018 |
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
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089342
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 0143-9517_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
N400143951701followed by a unit qualifier and the quantityPackage 00143-9517-01. 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 sing…
Excerpt only. Read the full label for complete information.
About NDC 0143-9517
- What is NDC 0143-9517?
- 0143-9517 is the product NDC for Methotrexate, Methotrexate 25 mg/mL solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methotrexate.
- What is the active ingredient?
- Methotrexate.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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?
- 51 other product NDCs are listed under this name. See all Methotrexate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methotrexate 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 | Methotrexate 2.5 mg/1 | TabletOral | American Health Packaging | 60687-975 | 60687-0975-94 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Alembic Pharmaceuticals Limited | 46708-711 | 46708-0711-05 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous | Alembic Pharmaceuticals Limited | 46708-712 | 46708-0712-01 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-711 | 62332-0711-05 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-712 | 62332-0712-01 |
| Methotrexate | Methotrexate 2.5 mg/1 | TabletOral | AvPAK | 50268-554 | 50268-0554-15 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Safecor Health LLC | 48433-065 | 48433-0065-05 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1524 | 67046-1524-03 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous | Hospira, Inc. | 61703-161 | 61703-0161-05 |
| Methotrexate | Methotrexate sodium 50 mg/2mL | Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous | Eugia US LLC | 55150-510 | 55150-0510-0155150-0510-05 |