HYDROXYUREA
- Product NDC
- 51407-909
- 11-digit product format
- 514070909
- Labeler code
- 51407
- Product ID
- 51407-909_27c291c3-aa28-97af-e063-6394a90a6565
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYUREA
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA213438
- Marketing category
- ANDA
- Marketing start
- 2020-04-08
- 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 |
|---|
| 51407-909-01 | HYDROXYUREA | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51407-909 | HYDROXYUREA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | Current NDC, 1 package rows | 20241212_1b42f2b4-3880-e7a9-e063-6294a90a5fd0.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 |
|---|
| 51407-909-01 | 51407090901 | 100 CAPSULE in 1 BOTTLE, PLASTIC (51407-909-01) | 100 capsule | 2024-04-22 | No | No | Historical |