DROXIA
- Product NDC
- 61269-402
- 11-digit product format
- 612690402
- Labeler code
- 61269
- Product ID
- 61269-402_f57fbea0-8124-4877-b7c6-f1b154d8c659
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYUREA
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- H2-Pharma LLC
- Application
- NDA016295
- Marketing category
- NDA
- Marketing start
- 2009-06-01
- Substance
- HYDROXYUREA
- Active strength
- 200 mg/1
- 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
- DROXIA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYUREA | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X6Q56QN5QC |
| Rxcui | 200342, 200343, 200344, 213282, 213283, 213284 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61269-402-60 | DROXIA | 60 in 1 BOTTLE | CAPSULE | 60 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61269-402 | DROXIA (HYDROXYUREA) CAPSULE [H2-PHARMA LLC] | 23 | Current NDC, Legacy NDC, 1 package rows | 20240817_a9494409-3571-4a81-9ad3-15ef7cb636a2.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 |
|---|
| 61269-402-60 | 61269040260 | 60 CAPSULE in 1 BOTTLE (61269-402-60) | 60 capsule | 2015-07-16 | 0000-00-00 | No | No | Current |