Deferasirox
- Product NDC
- 67877-553
- 11-digit product format
- 678770553
- Labeler code
- 67877
- Product ID
- 67877-553_5e8c386f-5879-4f68-bc6f-38041072f5ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Deferasirox
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA210555
- Marketing category
- ANDA
- Marketing start
- 2020-07-04
- 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 | 1607784, 1607792, 1607796 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-553-30 | Deferasirox | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 67877-553-90 | Deferasirox | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-553 | DEFERASIROX TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20220626_0fb210b3-6a3d-4313-83ce-52012e384f9b.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 |
|---|
| 67877-553-30 | 67877055330 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-553-30) | 2020-07-04 | 0000-00-00 | No | No | Current |
| 67877-553-90 | 67877055390 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-553-90) | 2020-07-04 | 0000-00-00 | No | No | Current |