Ibrance
- Product NDC
- 0069-0486
- 11-digit product format
- 000690486
- Labeler code
- 0069
- Product ID
- 0069-0486_01800bda-3788-40c5-976b-c054dda1c0b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- palbociclib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- 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
- 2027-12-31
- 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 |
|---|
| 0069-0486-03 | Ibrance | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 12 |
| 0069-0486-07 | Ibrance | 7 in 1 DOSE PACK | TABLET, FILM COATED | 7 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-0486 | IBRANCE (PALBOCICLIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250507_fecbdd7d-b729-41b5-9872-231b8fe104ce.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 |
|---|
| 0069-0486-03 | 00069048603 | 3 DOSE PACK in 1 CARTON (0069-0486-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0486-07) | 3 dose pack | 2020-03-30 | 0000-00-00 | No | No | Current |
| 0069-0486-07 | 00069048607 | 7 in 1 DOSE PACK | | | | | | Historical |