Deferasirox
- Product NDC
- 69452-160
- 11-digit product format
- 694520160
- Labeler code
- 69452
- Product ID
- 69452-160_2f9b625f-3835-4481-e063-6394a90a4bf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- deferasirox
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA210920
- Marketing category
- ANDA
- Marketing start
- 2018-09-28
- 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
- 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 | 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 |
|---|
| 69452-160-13 | Deferasirox | 30 in 1 BOTTLE | TABLET, FOR SUSPENSION | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-160 | DEFERASIROX TABLET, FOR SUSPENSION [BIONPHARMA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250308_dc690f20-533e-490e-b13d-143382e02351.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 |
|---|
| 69452-160-13 | 69452016013 | 30 TABLET, FOR SUSPENSION in 1 BOTTLE (69452-160-13) | 2018-09-28 | 0000-00-00 | No | No | Current |