Sorafenib
- Product NDC
- 0480-5425
- 11-digit product format
- 004805425
- Labeler code
- 0480
- Product ID
- 0480-5425_213b5f06-be1f-4bc1-b09d-86c12f83d3b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sorafenib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA209567
- Marketing category
- ANDA
- Marketing start
- 2023-01-03
- Substance
- SORAFENIB TOSYLATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sorafenib
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SORAFENIB TOSYLATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5T62Q3B36J |
| Rxcui | 597747 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-5425-89 | Sorafenib | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-5425 | SORAFENIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230105_dae598f7-823f-405c-ae31-f924594187b9.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 |
|---|
| 0480-5425-89 | 00480542589 | 120 TABLET, FILM COATED in 1 BOTTLE (0480-5425-89) | 2023-01-03 | 0000-00-00 | No | No | Current |