CAPRELSA
- Product NDC
- 58468-7840
- 11-digit product format
- 584687840
- Labeler code
- 58468
- Product ID
- 58468-7840_abb9eb38-c6a9-49e9-8e90-852f95773feb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vandetanib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Genzyme Corporation
- Application
- NDA022405
- Marketing category
- NDA
- Marketing start
- 2011-07-25
- Substance
- VANDETANIB
- Active strength
- 300 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], 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
- CAPRELSA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VANDETANIB | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YO460OQ37K |
| Rxcui | 1098416, 1098418, 1114074, 1114096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58468-7840-3 | CAPRELSA | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 14 |
| 58468-7840-3 | CAPRELSA | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58468-7840 | CAPRELSA (VANDETANIB) TABLET, FILM COATED [GENZYME CORPORATION] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250523_e5721cb8-4185-47b9-bbb3-1c587e558a03.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 |
|---|
| 58468-7840-3 | 58468784003 | 1 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2011-07-25 | 0000-00-00 | No | No | Current |