HYDROXYUREA
- Product NDC
- 67184-0607
- 11-digit product format
- 671840607
- Labeler code
- 67184
- Product ID
- 67184-0607_a252a0db-b5ce-49d2-b29d-461b34a41479
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYUREA
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA218021
- Marketing category
- ANDA
- Marketing start
- 2024-03-06
- 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 |
|---|
| 67184-0607-1 | HYDROXYUREA | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0607 | HYDROXYUREA CAPSULE [QILU PHARMACEUTICAL CO., LTD.] | 2 | Current NDC, 1 package rows | 20240601_4cd244d4-bd4a-41c8-b072-c2135787d412.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 |
|---|
| 67184-0607-1 | 67184060701 | 100 CAPSULE in 1 BOTTLE (67184-0607-1) | 100 capsule | 2024-03-06 | No | No | Current |