HYDROXYUREA
- Product NDC
- 67046-1619
- 11-digit product format
- 670461619
- Labeler code
- 67046
- Product ID
- 67046-1619_44fd4944-cb39-8ec8-e063-6394a90a8588
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYUREA
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA218021
- Marketing category
- ANDA
- Marketing start
- 2025-12-02
- Substance
- HYDROXYUREA
- Active strength
- 500 mg/1
- Pharmacologic classes
- Antimetabolite [EPC], Urea [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROXYUREA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYUREA | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X6Q56QN5QC |
| Rxcui | 197797 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1619-3 | HYDROXYUREA | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1619-3 | 67046161903 | 30 CAPSULE in 1 BLISTER PACK (67046-1619-3) | 30 capsule | 2025-12-02 | No | No | Historical |