NDC 0069-0284
Ibrance
Palbociclib
Ibrance is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Palbociclib.
| Product ID | 0069-0284_42b1133b-b05f-49ef-8710-a29937753b54 |
| NDC | 0069-0284 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ibrance |
| Generic Name | Palbociclib |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-03-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA212436 |
| Labeler Name | Pfizer Laboratories Div Pfizer Inc |
| Substance Name | PALBOCICLIB |
| Active Ingredient Strength | 75 mg/1 |
| Pharm Classes | Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0069-0284-03
3 DOSE PACK in 1 CARTON (0069-0284-03) > 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0284-07)
| Marketing Start Date | 2020-03-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0069-0284-03 [00069028403]
Ibrance TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA212436 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-03-30 |
NDC 0069-0284-07 [00069028407]
Ibrance TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA212436 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-03-30 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PALBOCICLIB | 75 mg/1 |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Kinase Inhibitors [MoA]
- Cytochrome P450 3A Inhibitors [MoA]
NDC Crossover Matching brand name "Ibrance" or generic name "Palbociclib"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0069-0187 | Ibrance | palbociclib |
| 0069-0188 | Ibrance | palbociclib |
| 0069-0189 | Ibrance | palbociclib |
| 0069-0284 | Ibrance | palbociclib |
| 0069-0486 | Ibrance | palbociclib |
| 0069-0688 | Ibrance | palbociclib |
| 63539-187 | Ibrance | palbociclib |
| 63539-188 | Ibrance | palbociclib |
| 63539-189 | Ibrance | palbociclib |
| 63539-284 | Ibrance | palbociclib |
| 63539-486 | Ibrance | palbociclib |
| 63539-688 | Ibrance | palbociclib |
Trademark Results [Ibrance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IBRANCE 86314613 4928206 Live/Registered |
Pfizer Inc. 2014-06-19 |
 IBRANCE 85444239 4518147 Live/Registered |
Pfizer Inc. 2011-10-11 |
 IBRANCE 77448185 not registered Dead/Abandoned |
Pfizer Inc. 2008-04-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.