Exjade
- Product NDC
- 0078-0468
- 11-digit product format
- 000780468
- Labeler code
- 0078
- Product ID
- 0078-0468_17c39217-5502-420d-8d2e-799626756189
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- deferasirox
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA021882
- Marketing category
- NDA
- Marketing start
- 2005-11-30
- Substance
- DEFERASIROX
- Active strength
- 125 mg/1
- Pharmacologic classes
- Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Exjade
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEFERASIROX | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V8G4MOF2V9 |
| Rxcui | 597768, 597770, 597772, 616159, 616161, 616163 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0468-15 | Exjade | 30 in 1 BOTTLE | TABLET, FOR SUSPENSION | 30 | | 49 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEFERASIROX | ACTIVE INGREDIENT | V8G4MOF2V9 | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | |
| DEFERASIROX | ACTIVE MOIETY | V8G4MOF2V9 | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0468 | EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 45 | Current NDC, Legacy NDC, 1 package rows | 20240724_3495a70c-870c-4968-940e-8baea152cf85.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0468-15 | 00078046815 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15) | 2005-11-30 | 0000-00-00 | No | No | Current |