DEFERASIROX
- Product NDC
- 62332-412
- 11-digit product format
- 623320412
- Labeler code
- 62332
- Product ID
- 62332-412_6d1323aa-ee46-43aa-bcf0-d83a36788a1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEFERASIROX
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA211824
- Marketing category
- ANDA
- Marketing start
- 2019-11-21
- 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 |
|---|
| 62332-412-30 | DEFERASIROX | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 17 |
| 62332-412-91 | DEFERASIROX | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-412 | DEFERASIROX TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20230527_f1f952c8-89f5-4a2f-bd6b-9b384366d971.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 |
|---|
| 62332-412-30 | 62332041230 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-412-30) | 2019-11-21 | 0000-00-00 | No | No | Current |
| 62332-412-91 | 62332041291 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-412-91) | 2019-11-21 | 0000-00-00 | No | No | Current |