Hydroxyurea
- Product NDC
- 49884-724
- 11-digit product format
- 498840724
- Labeler code
- 49884
- Product ID
- 49884-724_4413d36e-3573-4ba9-9baa-c0bbd5e254d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyurea
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA075340
- Marketing category
- ANDA
- Marketing start
- 1999-02-24
- 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
- Hydroxyurea
- 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 | 197797 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-724-01 | Hydroxyurea | 100 in 1 BOTTLE | CAPSULE | 100 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROXYUREA | ACTIVE INGREDIENT | X6Q56QN5QC | HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] | 7 | |
| HYDROXYUREA | ACTIVE MOIETY | X6Q56QN5QC | HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] | 7 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROXYUREA CAPSULE [PAR PHARMACEUTICAL, INC.] | 7 | |
| HYDROXYUREA | ACTIVE INGREDIENT | X6Q56QN5QC | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | |
| HYDROXYUREA | ACTIVE MOIETY | X6Q56QN5QC | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-724 | HYDROXYUREA CAPSULE [ENDO USA, INC.] | 22 | Current NDC, Legacy NDC, 1 package rows | 20240926_9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6.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 |
|---|
| 49884-724-01 | 49884072401 | 100 CAPSULE in 1 BOTTLE (49884-724-01) | 100 capsule | 1999-02-24 | 0000-00-00 | No | No | Current |