Hydroxyurea
- Product NDC
- 0904-6939
- 11-digit product format
- 009046939
- Labeler code
- 0904
- Product ID
- 0904-6939_554e6427-7d26-4f99-b69b-10468b9bb014
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyurea
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075340
- Marketing category
- ANDA
- Marketing start
- 1999-02-24
- 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
- 2027-12-31
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 |
|---|
| 0904-6939-61 | Hydroxyurea | 100 in 1 CARTON | CAPSULE | 100 | | 7 |
| 0904-6939-61 | Hydroxyurea | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6939 | HYDROXYUREA CAPSULE [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241018_e76fd60e-7644-48c5-9857-3608a045000b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6939-61 | 00904693961 | 100 BLISTER PACK in 1 CARTON (0904-6939-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 1999-02-24 | 0000-00-00 | No | No | Current |