XROMI
- Product NDC
- 62484-0015
- 11-digit product format
- 624840015
- Labeler code
- 62484
- Product ID
- 62484-0015_6eb58656-a29b-4edb-966f-bc9a13a78775
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyurea
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Nova Laboratories, Ltd.
- Application
- NDA216593
- Marketing category
- NDA
- Marketing start
- 2024-04-04
- Substance
- HYDROXYUREA
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Antimetabolite [EPC], Urea [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- XROMI
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYUREA | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X6Q56QN5QC |
| Rxcui | 2682741, 2696079 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62484-0015-4 | XROMI | 148 mL in 1 BOTTLE | SOLUTION | 148 | | 10 |
| 62484-0015-5 | XROMI | 1 in 1 CARTON | SOLUTION | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62484-0015 | XROMI (HYDROXYUREA) SOLUTION [NOVA LABORATORIES, LTD.] | 7 | Current NDC, 2 package rows | 20250105_4b37d336-86da-4363-aef1-34a7d3ba973b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62484-0015-4 | 62484001504 | 148 mL in 1 BOTTLE | 148 ml | | | | Historical |
| 62484-0015-5 | 62484001505 | 1 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4) | 1 bottle | 2024-04-04 | No | No | Historical |