NDC codes

FDA NDC Directory
Product NDC (as listed)52652-2001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52652-2001Add 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 NDC11-digit (billing)PackageCopy
52652-2001-15265220010152652200101120 mL in 1 BOTTLE (52652-2001-1)Marketed from May 1, 2017
52652-2001-6526522001065265220010660 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

N452652200101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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