HYDROXYUREA
- Product NDC
- 70518-3615
- 11-digit product format
- 705183615
- Labeler code
- 70518
- Product ID
- 70518-3615_f1ffbc60-1388-2b82-e053-2995a90a9111
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYUREA
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA213438
- Marketing category
- ANDA
- Marketing start
- 2023-01-10
- Marketing end
- 0000-00-00
- Substance
- HYDROXYUREA
- Active strength
- 500 mg/1
- Pharmacologic classes
- Antimetabolite [EPC], Urea [CS]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3615 | HYDROXYUREA CAPSULE [REMEDYREPACK INC.] | 4 | Legacy NDC | 20241122_0dd79b2b-e0fa-4581-9c38-bf9a909ccb62.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3615-0 | 70518361500 | 30 CAPSULE in 1 BLISTER PACK (70518-3615-0) | 30 capsule | 2023-01-10 | 0000-00-00 | No | No | Current |