FDA.reportPublic FDA data

NDC 62484-0015-05 - XROMI

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
62484-0015
Requested NDC
62484-0015-05
Package NDCs from labels
62484-0015-4, 62484-0015-5, 62484-0015-05
Manufacturer
Nova Laboratories, Ltd. | Rare Disease Therapeutics, Inc. | Nova Laboratories, Ltd
Effective date
2026-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XROMI - Nova Laboratories, Ltd. | Rare Disease Therapeutics, Inc. | Nova Laboratories, LtdNova Laboratories, Ltd. | Rare Disease Therapeutics, Inc. | Nova Laboratories, Ltd2026-02-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62484-0015-4XROMI148 mL in 1 BOTTLESOLUTION14810
62484-0015-5XROMI1 in 1 CARTONSOLUTION110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62484-0015XROMI (HYDROXYUREA) SOLUTION [NOVA LABORATORIES, LTD.]7Current NDC, 2 package rows20250105_4b37d336-86da-4363-aef1-34a7d3ba973b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62484-0015-4ML - Milliliter62484-0015111707d6-3307-4d5f-9438-5d129ab3488112025-03-04
62484-0015-5ML - Milliliter62484-0015a1a06064-f010-4988-891b-23d18d367aac12025-03-04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydroxyureaHYDROXYUREAMajor Pharmaceuticalse76fd60e-7644-48c5-9857-3608a045000b2026-05-27Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HydroxyureaHYDROXYUREAPar Health USA, LLC9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a62026-05-07Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HydroxyureaHYDROXYUREAAmerican Health Packagingc84a2241-6c05-480f-8a5b-049e08c27d732026-03-02Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
XROMIHYDROXYUREANova Laboratories, Ltd.4b37d336-86da-4363-aef1-34a7d3ba973b2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA216593
ndc (package): 62484-0015-4
ndc (package): 62484-0015-5
ndc (product): 62484-0015
ndc11 (package): 62484001505
rxcui: 2696079
rxcui: 2682741
spl id: 6eb58656-a29b-4edb-966f-bc9a13a78775
spl set id: 4b37d336-86da-4363-aef1-34a7d3ba973b
unii: X6Q56QN5QC
HYDREAHYDROXYUREAH2-Pharma LLC6053c775-68de-45e4-9af9-33b18fd0e1402026-01-26Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
DROXIAHYDROXYUREAH2-Pharma LLCa9494409-3571-4a81-9ad3-15ef7cb636a22026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
SiklosHYDROXYUREAMedunik76957c0d-0f98-4376-bb06-eee651adc09d2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HYDROXYUREAHYDROXYUREACoupler LLC44fd5379-5fb0-ff62-e063-6294a90ac7922025-12-02Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HYDROXYUREAHYDROXYUREAAvKARE862583ff-6d5c-3f7d-e3bd-352fb04009282025-10-15Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HYDREAHYDROXYUREAWaylis Therapeutics LLC8d41152f-a98a-4abc-afdf-a909012434a02025-09-15Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
DROXIAHYDROXYUREAWaylis Therapeutics LLC4ad13dc6-a2ab-4308-96b3-7c642c92cc232025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HYDROXYUREAHYDROXYUREAGolden State Medical Supply, Inc.1b42f2b4-3880-e7a9-e063-6294a90a5fd02024-11-25Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HYDROXYUREAHYDROXYUREALeading Pharma, LLC4c4e1c2f-2143-44f3-8825-aeba42e755e42024-10-29Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HYDROXYUREAHYDROXYUREASomerset Therapeutics, LLC9752a347-b42c-44d5-8fd1-c538f7f239dc2024-09-23Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HYDROXYUREAHYDROXYUREATeva Pharmaceuticals USA, Inc.b9514ae5-79ae-4cc2-9d7f-c8f7806d16942024-05-30Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC
HYDROXYUREAHYDROXYUREAQilu Pharmaceutical Co., Ltd.4cd244d4-bd4a-41c8-b072-c2135787d4122024-04-30Warnings, Adverse reactionsExact identifier
unii: X6Q56QN5QC

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.