Hydroxyurea
- Product NDC
- 70518-0916
- 11-digit product format
- 705180916
- Labeler code
- 70518
- Product ID
- 70518-0916_f034e7cd-56db-8a85-e053-2995a90af991
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyurea
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075340
- Marketing category
- ANDA
- Marketing start
- 2017-12-20
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-0916-0 | 70518091600 | 30 CAPSULE in 1 BLISTER PACK (70518-0916-0) | 30 capsule | 2017-12-20 | 0000-00-00 | No | No | Current |
| 70518-0916-1 | 70518091601 | 100 POUCH in 1 BOX (70518-0916-1) > 1 CAPSULE in 1 POUCH (70518-0916-2) | 100 pouch | 2019-12-18 | 0000-00-00 | No | No | Current |