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NDC 00069-0486-03 Ibrance 100 mg/1 Details
Ibrance 100 mg/1
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.
MedlinePlus Drug Summary
Palbociclib is used in combination with anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara) to treat a certain type of hormone receptor–positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer that has spread to other parts of the body in women who have experienced menopause (change of life; end of monthly menstrual periods) or in men. Palbociclib is also used along with fulvestrant (Faslodex) to treat a certain type of hormone receptor–positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer that has spread to other parts of the body in people who have been treated with an antiestrogen medication such as tamoxifen (Nolvadex). Palbociclib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.
Related Packages: 00069-0486-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Palbociclib
Product Information
| NDC | 00069-0486 |
|---|---|
| Product ID | 0069-0486_6e5e2b14-bbfe-4f85-88ee-d516c6ac2536 |
| Associated GPIs | 21531060000330 |
| GCN Sequence Number | 080427 |
| GCN Sequence Number Description | palbociclib TABLET 100 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 47257 |
| HICL Sequence Number | 041725 |
| HICL Sequence Number Description | PALBOCICLIB |
| Brand/Generic | Brand |
| Proprietary Name | Ibrance |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | palbociclib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | PALBOCICLIB |
| Labeler Name | Pfizer Laboratories Div Pfizer Inc |
| Pharmaceutical Class | Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA212436 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00069-0486-03 (00069048603)
| NDC Package Code | 0069-0486-03 |
|---|---|
| Billing NDC | 00069048603 |
| Package | 3 DOSE PACK in 1 CARTON (0069-0486-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0486-07) |
| Marketing Start Date | 2020-03-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |