DEFERASIROX
- Product NDC
- 59651-448
- 11-digit product format
- 596510448
- Labeler code
- 59651
- Product ID
- 59651-448_c220484e-1e6a-4a0c-a221-60223f3bc24c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEFERASIROX
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA215137
- Marketing category
- ANDA
- Marketing start
- 2025-09-08
- Substance
- DEFERASIROX
- Active strength
- 180 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DEFERASIROX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEFERASIROX | 180 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V8G4MOF2V9 |
| Rxcui | 1923822, 1923826, 1923828 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-448-30 | DEFERASIROX | 30 in 1 CARTON | GRANULE | 30 | | 1 |
| 59651-448-77 | DEFERASIROX | 1 in 1 PACKET | GRANULE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-448-30 | 59651044830 | 30 PACKET in 1 CARTON (59651-448-30) / 1 GRANULE in 1 PACKET (59651-448-77) | 30 packet | 2025-09-08 | No | No | Current |
| 59651-448-77 | 59651044877 | 1 in 1 PACKET | | | | | Historical |