xromi

Generic: hydroxyurea

Labeler: nova laboratories, ltd.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xromi
Generic Name hydroxyurea
Labeler nova laboratories, ltd.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

hydroxyurea 100 mg/mL

Manufacturer
Nova Laboratories, Ltd.

Identifiers & Regulatory

Product NDC 62484-0015
Product ID 62484-0015_6eb58656-a29b-4edb-966f-bc9a13a78775
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216593
Listing Expiration 2027-12-31
Marketing Start 2024-04-04

Pharmacologic Class

Established (EPC)
antimetabolite [epc]
Chemical Structure
urea [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 624840015
Hyphenated Format 62484-0015

Supplemental Identifiers

RxCUI
2682741 2696079
UPC
0362484001547
UNII
X6Q56QN5QC
NUI
N0000180853 M0022315

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xromi (source: ndc)
Generic Name hydroxyurea (source: ndc)
Application Number NDA216593 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4)
source: ndc

Packages (1)

62484-0015-5 1 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4)

Ingredients (1)

hydroxyurea (100 mg/mL)

Linked Drug Pages (1)

XROMI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6eb58656-a29b-4edb-966f-bc9a13a78775", "openfda": {"nui": ["N0000180853", "M0022315"], "upc": ["0362484001547"], "unii": ["X6Q56QN5QC"], "rxcui": ["2682741", "2696079"], "spl_set_id": ["4b37d336-86da-4363-aef1-34a7d3ba973b"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Nova Laboratories, Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (62484-0015-5)  / 148 mL in 1 BOTTLE (62484-0015-4)", "package_ndc": "62484-0015-5", "marketing_start_date": "20240404"}], "brand_name": "XROMI", "product_id": "62484-0015_6eb58656-a29b-4edb-966f-bc9a13a78775", "dosage_form": "SOLUTION", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "62484-0015", "generic_name": "Hydroxyurea", "labeler_name": "Nova Laboratories, Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XROMI", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "100 mg/mL"}], "application_number": "NDA216593", "marketing_category": "NDA", "marketing_start_date": "20240404", "listing_expiration_date": "20271231"}