Prescription drug · NDA
Xromi (Hydroxyurea) NDC 62484-0015
Hydroxyurea 100 mg/mL · Solution · Oral · Nova Laboratories, Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62484-0015-5 | 62484001505 | 1 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
N462484001505followed by a unit qualifier and the quantityPackage 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.
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.