Prescription drug · ANDA
Methotrexate NDC 48433-065
Methotrexate sodium 2.5 mg/1 · Tablet · Oral · Safecor Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-065-05 | 4843300650548433006505 | 20 BLISTER PACK in 1 CARTON (48433-065-05) / 1 TABLET in 1 BLISTER PACK (48433-065-01)Marketed from Jan 19, 2026 |
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
- Active ingredients
- Methotrexate sodium — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Safecor Health LLCNDC labeler code 48433
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 081235
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 48433-065_49a1fdee-5587-e05a-e063-6294a90aebc5SPL ID 49a1fdee-5587-e05a-e063-6294a90aebc5SPL set ID f177e6fa-c482-432d-8208-937468ab3f10RxCUI 105585UNII 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 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
N448433006505followed by a unit qualifier and the quantityPackage 48433-0065-05. 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 dihydrofolate 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 adults and pediatr…
Excerpt only. Read the full label for complete information.
About NDC 48433-065
- What is NDC 48433-065?
- 48433-065 is the product NDC for Methotrexate, Methotrexate sodium 2.5 mg/1 tablet, listed with the FDA by Safecor Health LLC. 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 sodium.
- Who is the labeler?
- Safecor Health LLC, NDC labeler code 48433. 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 | 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 |
| Methotrexate | Methotrexate sodium 100 mg/4mL | Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous | Eugia US LLC | 55150-511 | 55150-0511-0155150-0511-10 |
Other NDCs under ANDA 081235
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 2.5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0014 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-670 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-121 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1118 |