Prescription drug · NDA
Rasuvo (methotrexate) NDC 59137-515
Methotrexate sodium 12.5 mg/.25mL · Injection, Solution · Subcutaneous · Medexus Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59137-515-01 | 59137051501 | 1 PACKAGE in 1 CARTON (59137-515-01) / .25 mL in 1 PACKAGE (59137-515-00)Marketed from Jul 10, 2014 | |
| 59137-515-04 | 59137051504 | 4 PACKAGE in 1 CARTON (59137-515-04) / .25 mL in 1 PACKAGE (59137-515-00)Marketed from Jul 10, 2014 |
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)
- Rasuvo
- Generic name (nonproprietary)
- methotrexate
- Active ingredients
- Methotrexate sodium — 12.5 mg/.25mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Medexus Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205776
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 59137-515_29d04017-dd64-4dea-a064-7b3b0805f423SPL ID 29d04017-dd64-4dea-a064-7b3b0805f423SPL set ID d0075461-0e7e-4967-9c9b-d6440e912c0eRxCUI 1441416, 1544378, 1544383, 1544385, 1544386, 1544387, 1544388, 1544389, 1544390, 1544394, 1544395, 1544396, 1544397, 1544398, 1544401, 1544402, 1544403, 1544404UNII 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
N459137051501followed by a unit qualifier and the quantityPackage 59137-0515-01. 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)
Rasuvo is a folate analog metabolic inhibitor indicated for the: Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy ( 1.1 ) Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy ( 1.2 ) Limitation of Use Rasuvo is not indicated for the treatment of neoplastic diseases ( 1.3 ). 1.1 Rheumatoid Arthritis including Polyarticular Juvenile Idiopathic Arthritis Rasuvo is indicated in the management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criter…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205776
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 |
|---|---|---|---|---|
| Rasuvomethotrexate | Methotrexate sodium 7.5 mg/.15mL | Injection, SolutionSubcutaneous | Medexus Pharma Inc. | 59137-505 |
| Rasuvomethotrexate | Methotrexate sodium 10 mg/.2mL | Injection, SolutionSubcutaneous | Medexus Pharma Inc. | 59137-510 |
| Rasuvomethotrexate | Methotrexate sodium 20 mg/.4mL | Injection, SolutionSubcutaneous | Medexus Pharma Inc. | 59137-530 |
| Rasuvomethotrexate | Methotrexate sodium 15 mg/.3mL | Injection, SolutionSubcutaneous | Medexus Pharma Inc. | 59137-520 |
| Rasuvomethotrexate | Methotrexate sodium 17.5 mg/.35mL | Injection, SolutionSubcutaneous | Medexus Pharma Inc. | 59137-525 |
| Rasuvomethotrexate | Methotrexate sodium 22.5 mg/.45mL | Injection, SolutionSubcutaneous | Medexus Pharma Inc. | 59137-535 |
| Rasuvomethotrexate | Methotrexate sodium 25 mg/.5mL | Injection, SolutionSubcutaneous | Medexus Pharma Inc. | 59137-540 |
| Rasuvomethotrexate | Methotrexate sodium 30 mg/.6mL | Injection, SolutionSubcutaneous | Medexus Pharma Inc. | 59137-550 |