DROXIA
- Product NDC
- 0003-6335
- 11-digit product format
- 000036335
- Labeler code
- 0003
- Product ID
- 0003-6335_4e5c3df1-3e9c-4eb1-959e-1ab30dbb84f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYUREA
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Application
- NDA016295
- Marketing category
- NDA
- Marketing start
- 2009-06-01
- Marketing end
- 2025-03-31
- Substance
- HYDROXYUREA
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antimetabolite [EPC], Urea [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| hydroxyurea | ACTIVE INGREDIENT | X6Q56QN5QC | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| hydroxyurea | ACTIVE MOIETY | X6Q56QN5QC | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| D&C Red No. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| D&C Red No. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| FD&C Green No. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| sodium phosphate | INACTIVE INGREDIENT | SE337SVY37 | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0003-6335 | DROXIA (HYDROXYUREA) CAPSULE [E.R. SQUIBB & SONS, L.L.C.] | 19 | Legacy NDC | 20221129_740e054b-faac-7c27-f06d-a56efb699355.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0003-6335-17 | 00003633517 | 60 CAPSULE in 1 BOTTLE (0003-6335-17) | 60 capsule | 2015-07-16 | 0000-00-00 | No | No | Current |