HYDROXYUREA
- Product NDC
- 69315-164
- 11-digit product format
- 693150164
- Labeler code
- 69315
- Product ID
- 69315-164_3706a800-8ea5-4593-9c7b-5083978b559b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYUREA
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA213438
- Marketing category
- ANDA
- Marketing start
- 2020-07-09
- 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 |
|---|
| 69315-164-01 | HYDROXYUREA | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-164 | HYDROXYUREA CAPSULE [LEADING PHARMA, LLC] | 11 | Current NDC, Legacy NDC, 1 package rows | 20241030_4c4e1c2f-2143-44f3-8825-aeba42e755e4.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 |
|---|
| 69315-164-01 | 69315016401 | 100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01) | 100 capsule | 2020-07-09 | 0000-00-00 | No | No | Current |