NDC codes

FDA NDC Directory
Product NDC (as listed)62484-0015Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62484-0015Add 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
62484-0015-5624840015051 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4)Marketed from Apr 4, 2024

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)
Xromi
Generic name (nonproprietary)
hydroxyurea
Active ingredients
Hydroxyurea — 100 mg/mL
Dosage form
Solution
Route
Oral
Labeler
Nova Laboratories, Ltd.NDC labeler code 62484
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 216593
Marketing start
Listing expires
Other FDA classes
Urea (Chemical structure)
Identifiers
Product ID 62484-0015_6eb58656-a29b-4edb-966f-bc9a13a78775SPL ID 6eb58656-a29b-4edb-966f-bc9a13a78775SPL set ID 4b37d336-86da-4363-aef1-34a7d3ba973bRxCUI 2682741, 2696079UNII X6Q56QN5QCUPC 0362484001547
Pharmacologic class
Antimetabolite

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

N462484001505 followed by a unit qualifier and the quantity

Package 62484-0015-05. 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)

XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises. XROMI is an antimetabolite indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62484-0015

What is NDC 62484-0015?
62484-0015 is the product NDC for Xromi (hydroxyurea), Hydroxyurea 100 mg/mL solution, listed with the FDA by Nova Laboratories, Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Xromi (Hydroxyurea).
What is the active ingredient?
Hydroxyurea.
Who is the labeler?
Nova Laboratories, Ltd., NDC labeler code 62484. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Xromi?
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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