Ibrance
- Product NDC
- 63539-486
- 11-digit product format
- 635390486
- Labeler code
- 63539
- Product ID
- 63539-486_bdba8a62-3a62-4485-a053-e496ad7dda13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- palbociclib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA212436
- Marketing category
- NDA
- Marketing start
- 2020-03-30
- Substance
- PALBOCICLIB
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], 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
- Ibrance
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PALBOCICLIB | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G9ZF61LE7G |
| Rxcui | 2284102, 2284104, 2284105, 2284106, 2284107, 2284108 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63539-486-03 | Ibrance | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 9 |
| 63539-486-07 | Ibrance | 7 in 1 DOSE PACK | TABLET, FILM COATED | 7 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-486 | IBRANCE (PALBOCICLIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250426_89a142d5-7e61-48bf-9e77-e2cd124c4792.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63539-486-03 | 63539048603 | 3 DOSE PACK in 1 CARTON (63539-486-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (63539-486-07) | 3 dose pack | 2020-03-30 | 0000-00-00 | No | No | Current |
| 63539-486-07 | 63539048607 | 7 in 1 DOSE PACK | | | | | | Historical |