Pazopanib
- Product NDC
- 63304-116
- 11-digit product format
- 633040116
- Labeler code
- 63304
- Product ID
- 63304-116_893f0d84-70b8-41c6-bc13-19031fb43669
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pazopanib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- SUN PHARMACEUTICAL INDUSTRIES, INC.
- Application
- ANDA215837
- Marketing category
- ANDA
- Marketing start
- 2023-10-20
- Substance
- PAZOPANIB HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], 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
- Pazopanib
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAZOPANIB HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33Y9ANM545 |
| Rxcui | 867502 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-116-13 | Pazopanib | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 4 |
| 63304-116-30 | Pazopanib | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-116 | PAZOPANIB TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 3 | Current NDC, 2 package rows | 20240221_d3e8dd09-d7d2-43da-8f63-bdf0ea0fcdf5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63304-116-13 | 63304011613 | 120 TABLET, FILM COATED in 1 BOTTLE (63304-116-13) | 2023-10-20 | No | No | Current |
| 63304-116-30 | 63304011630 | 30 TABLET, FILM COATED in 1 BOTTLE (63304-116-30) | 2023-10-20 | No | No | Current |