Prescription drug · NDA
Xatmep (Methotrexate) NDC 52652-2001
Methotrexate 2.5 mg/mL · Solution · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52652-2001-1 | 5265220010152652200101 | 120 mL in 1 BOTTLE (52652-2001-1)Marketed from May 1, 2017 | |
| 52652-2001-6 | 5265220010652652200106 | 60 mL in 1 BOTTLE (52652-2001-6)Marketed from Aug 13, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Xatmep
- Generic name (nonproprietary)
- methotrexate
- Active ingredients
- Methotrexate — 2.5 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 52652
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208400
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 52652-2001_4e3b0925-2cdc-4743-91cf-860d98dd4661SPL ID 4e3b0925-2cdc-4743-91cf-860d98dd4661SPL set ID aec9984e-34c5-481b-b6bf-9bb5caf1daf8RxCUI 1921592, 1921598UNII 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 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
N452652200101followed by a unit qualifier and the quantityPackage 52652-2001-01. 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)
XATMEP is a folate analog metabolic inhibitor indicated for the: Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen ( 1.1 ). Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy ( 1.2 ). 1.1 Acute Lymphoblastic Leukemia XATMEP is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen. 1.2 Polyarticular Juvenile Idiopathic Arthritis XATMEP is indicated in the management of pediatric patien…
Excerpt only. Read the full label for complete information.
About NDC 52652-2001
- What is NDC 52652-2001?
- 52652-2001 is the product NDC for Xatmep (methotrexate), Methotrexate 2.5 mg/mL solution, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xatmep (Methotrexate).
- What is the active ingredient?
- Methotrexate.
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 52652. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xatmep?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.