Deferasirox
- Product NDC
- 45963-455
- 11-digit product format
- 459630455
- Labeler code
- 45963
- Product ID
- 45963-455_daefa0d6-0d5a-48fe-897b-cbc3e1db47f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Deferasirox
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA203560
- Marketing category
- ANDA
- Marketing start
- 2019-03-22
- Marketing end
- 2026-09-30
- Substance
- DEFERASIROX
- Active strength
- 250 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Deferasirox
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEFERASIROX | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V8G4MOF2V9 |
| Rxcui | 597768, 597770, 597772 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45963-455-30 | Deferasirox | 30 in 1 BOTTLE | TABLET, FOR SUSPENSION | 30 | | 29 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-455 | DEFERASIROX TABLET, FOR SUSPENSION [ACTAVIS PHARMA, INC.] | 28 | Current NDC, Legacy NDC, 1 package rows | 20241103_ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95.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 |
|---|
| 45963-455-30 | 45963045530 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-455-30) | 2019-03-22 | 2026-09-30 | No | No | Current |