Otrexup (methotrexate) NDC 54436-022

NDC codes

FDA NDC Directory

Product NDC (as listed)54436-022Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54436-0022Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
54436-022-01	54436002201	1 SYRINGE in 1 CARTON (54436-022-01) / .4 mL in 1 SYRINGEMarketed from Mar 24, 2016
54436-022-03	54436002203	1 SYRINGE in 1 CARTON (54436-022-03) / .4 mL in 1 SYRINGEMarketed from Mar 24, 2016 · Sample package
54436-022-04	54436002204	4 SYRINGE in 1 CARTON (54436-022-04) / .4 mL in 1 SYRINGE (54436-022-02)Marketed from Mar 24, 2016

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 — 22.5 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: Oct 11, 2013
Marketing end: Apr 30, 2027
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 54436-022_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.

How CPT relates to drug billing

NDC on a medical claim

N454436002201 followed by a unit qualifier and the quantity

Package 54436-0022-01. 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 Jan 31, 2025. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 204824

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 204824
Product	Strength	Form · route	Labeler	Product NDC
Otrexupmethotrexate	Methotrexate 17.5 mg/.4mL	Injection, SolutionSubcutaneous	Antares Pharma, Inc.	54436-017
Otrexupmethotrexate	Methotrexate 10 mg/.4mL	Injection, SolutionSubcutaneous	Antares Pharma, Inc.	54436-010
Otrexupmethotrexate	Methotrexate 12.5 mg/.4mL	Injection, SolutionSubcutaneous	Antares Pharma, Inc.	54436-012
Otrexupmethotrexate	Methotrexate 15 mg/.4mL	Injection, SolutionSubcutaneous	Antares Pharma, Inc.	54436-015
Otrexupmethotrexate	Methotrexate 20 mg/.4mL	Injection, SolutionSubcutaneous	Antares Pharma, Inc.	54436-020
Otrexupmethotrexate	Methotrexate 25 mg/.4mL	Injection, SolutionSubcutaneous	Antares Pharma, Inc.	54436-025