Prescription drug · ANDA
Methotrexate (Methotrexate sodium) NDC 63323-122
Methotrexate sodium 1 g/1 · Injection, Powder, Lyophilized, For solution · Intra-arterial, Intramuscular, Intrathecal, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-122-50 | 6332301225063323012250 | 1 VIAL in 1 CARTON (63323-122-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Jan 22, 2000 |
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
- Generic name (nonproprietary)
- methotrexate sodium
- Active ingredients
- Methotrexate sodium — 1 g/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intra-arterial, Intramuscular, Intrathecal, Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040266
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 63323-122_3d21237a-ef53-4592-bf06-0c739696203dSPL ID 3d21237a-ef53-4592-bf06-0c739696203dSPL set ID ec476b11-0b3c-4139-b1eb-a3daa76bc271RxCUI 311625UNII 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
N463323012250followed by a unit qualifier and the quantityPackage 63323-0122-50. 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 for Injection is a folate analog metabolic inhibitor indicated for: • The following neoplastic diseases for the: o Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen ( 1.1 ) o Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia ( 1.2 ) o Treatment of adult and pediatric patients with non-Hodgkin lymphoma ( 1.3 ) o Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen ( 1.4 ) o Treatment of adults with breast cancer as part of a combination chemotherapy regimen ( 1.5 ) o Treatment of adults with squamous cell carcinoma of the hea…
Excerpt only. Read the full label for complete information.
About NDC 63323-122
- What is NDC 63323-122?
- 63323-122 is the product NDC for Methotrexate (methotrexate sodium), Methotrexate sodium 1 g/1 injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methotrexate (Methotrexate sodium).
- What is the active ingredient?
- Methotrexate sodium.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 |