Sorafenib
- Product NDC
- 13668-682
- 11-digit product format
- 136680682
- Labeler code
- 13668
- Product ID
- 13668-682_27389dc4-60cc-4c65-92e6-97bcc09f7d20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sorafenib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA217095
- Marketing category
- ANDA
- Marketing start
- 2023-04-12
- Substance
- SORAFENIB
- Active strength
- 200 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sorafenib
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SORAFENIB | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9ZOQ3TZI87 |
| Rxcui | 597747 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-682-12 | Sorafenib | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 5 |
| 13668-682-30 | Sorafenib | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 5 |
| 13668-682-60 | Sorafenib | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 5 |
| 13668-682-74 | Sorafenib | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 5 |
| 13668-682-74 | Sorafenib | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-682 | SORAFENIB TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED] | 4 | Current NDC, 5 package rows | 20241103_b5305e23-7bc6-44d8-b177-930c47d1653a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 13668-682-12 | 13668068212 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12) | | 2023-04-12 | No | No | Current |
| 13668-682-30 | 13668068230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30) | | 2023-04-12 | No | No | Current |
| 13668-682-60 | 13668068260 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60) | | 2023-04-12 | No | No | Current |
| 13668-682-74 | 13668068274 | 10 BLISTER PACK in 1 CARTON (13668-682-74) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2023-04-12 | No | No | Current |