DEFERASIROX
- Product NDC
- 59651-412
- 11-digit product format
- 596510412
- Labeler code
- 59651
- Product ID
- 59651-412_3b584d19-7a28-43b4-86db-756caf83709a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEFERASIROX
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA214474
- Marketing category
- ANDA
- Marketing start
- 2023-10-16
- Substance
- DEFERASIROX
- Active strength
- 360 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 | 360 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V8G4MOF2V9 |
| Rxcui | 1607784, 1607792, 1607796 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-412-30 | DEFERASIROX | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-412 | DEFERASIROX TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 3 | Current NDC, 1 package rows | 20240511_c7f14819-1abc-4abf-b55b-cf89beaf124e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-412-30 | 59651041230 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-412-30) | 2023-10-16 | No | No | Current |