HYDREA
- Product NDC
- 61269-835
- 11-digit product format
- 612690835
- Labeler code
- 61269
- Product ID
- 61269-835_936d1231-1661-44c9-9eb9-0de1d3bf48cb
- 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
- 500 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
- HYDREA
- 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 | 105602, 197797 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61269-835-10 | HYDREA | 100 in 1 BOTTLE | CAPSULE | 100 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61269-835 | HYDREA (HYDROXYUREA) CAPSULE [H2-PHARMA LLC] | 19 | Current NDC, Legacy NDC, 1 package rows | 20240817_6053c775-68de-45e4-9af9-33b18fd0e140.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 |
|---|
| 61269-835-10 | 61269083510 | 100 CAPSULE in 1 BOTTLE (61269-835-10) | 100 capsule | 2009-06-01 | 0000-00-00 | No | No | Current |