Deferasirox
- Product NDC
- 69097-560
- 11-digit product format
- 690970560
- Labeler code
- 69097
- Product ID
- 69097-560_ce7e02d0-319e-4a5b-87e1-c6550ab4322c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Deferasirox
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA215026
- Marketing category
- ANDA
- Marketing start
- 2022-02-23
- 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 |
|---|
| 69097-560-53 | Deferasirox | 30 in 1 CARTON | GRANULE | 30 | | 1 |
| 69097-560-53 | Deferasirox | 1 in 1 PACKET | GRANULE | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-560 | DEFERASIROX GRANULE [CIPLA USA INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220304_31c5a91f-e901-418b-a519-779a0c245477.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69097-560-53 | 69097056053 | 30 PACKET in 1 CARTON (69097-560-53) / 1 GRANULE in 1 PACKET | 30 packet | 2022-02-23 | 0000-00-00 | No | No | Current |