Prescription drug · NDA
Otrexup (methotrexate) NDC 54436-025
Methotrexate 25 mg/.4mL · Injection, Solution · Subcutaneous · Antares Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54436-025-01 | 54436002501 | 1 SYRINGE in 1 CARTON (54436-025-01) / .4 mL in 1 SYRINGEMarketed from Oct 11, 2013 | |
| 54436-025-03 | 54436002503 | 1 SYRINGE in 1 CARTON (54436-025-03) / .4 mL in 1 SYRINGEMarketed from Oct 11, 2013 · Sample package | |
| 54436-025-04 | 54436002504 | 4 SYRINGE in 1 CARTON (54436-025-04) / .4 mL in 1 SYRINGE (54436-025-02)Marketed from Oct 11, 2013 |
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)
- Otrexup
- Generic name (nonproprietary)
- methotrexate
- Active ingredients
- Methotrexate — 25 mg/.4mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Antares Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204824
- Marketing start
- Marketing end
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 54436-025_2d07eb50-d314-a6a0-e063-6394a90ac970SPL ID 2d07eb50-d314-a6a0-e063-6394a90ac970SPL set ID 9ab8ce16-f7de-41d4-a4c8-1c742621b6d5RxCUI 1441402, 1441407, 1441411, 1441413, 1441416, 1441418, 1441422, 1441424, 1594757, 1594759, 1747179, 1747181, 1747185, 1747187, 1747192, 1747194UNII 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
N454436002501followed by a unit qualifier and the quantityPackage 54436-0025-01. 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)
Otrexup 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 Otrexup is not indicated for the treatment of neoplastic diseases ( 1.3 ). 1.1 Rheumatoid Arthritis including Polyarticular Juvenile Idiopathic Arthritis Otrexup is indicated in the management of selected adults with severe, active rheumatoid arthritis (RA) (A…
Excerpt only. Read the full label for complete information.