VANRAFIA
- Product NDC
- 0078-1420
- 11-digit product format
- 000781420
- Labeler code
- 0078
- Product ID
- 0078-1420_af74a97e-160b-4335-9bc5-97a29e721d1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atrasentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA219208
- Marketing category
- NDA
- Marketing start
- 2025-04-02
- Substance
- ATRASENTAN HYDROCHLORIDE
- Active strength
- .75 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VANRAFIA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATRASENTAN HYDROCHLORIDE | .75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | E4G31X93ZA |
| Rxcui | 2710454, 2710460 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-1420-15 | VANRAFIA | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-1420 | VANRAFIA (ATRASENTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] | 1 | Current NDC, 1 package rows | 20250406_9a7e7f85-bfd0-44a0-beda-3bcfa8215c64.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0078-1420-15 | 00078142015 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15) | 2025-04-02 | No | No | Historical |