IBRANCE (palbociclib) is supplied in the following strengths and package configurations:
| IBRANCE Capsules / Tablets | ||
|---|---|---|
| Package Configuration | Capsule / Tablet Strength (mg) | Dosage Form Description |
| Bottles of 21 capsules | 125 | opaque, hard gelatin capsules, size 0, with caramel cap and body, printed with white ink “Pfizer” on the cap, “PBC 125” on the body |
| Bottles of 21 capsules | 100 | opaque, hard gelatin capsules, size 1, with caramel cap and light orange body, printed with white ink “Pfizer” on the cap, “PBC 100” on the body |
| Bottles of 21 capsules | 75 | opaque, hard gelatin capsules, size 2, with light orange cap and body, printed with white ink “Pfizer” on the cap, “PBC 75” on the body |
| Box containing 3 weekly blister packs of 7 tablets each (21 tablets total) | 125 | Oval, light purple, film-coated tablets debossed with “Pfizer” on one side and “PBC 125” on the other side. |
| Box containing 3 weekly blister packs of 7 tablets each (21 tablets total) | 100 | Oval, green, film-coated tablets debossed with “Pfizer” on one side and “PBC 100” on the other side. |
| Box containing 3 weekly blister packs of 7 tablets each (21 tablets total) | 75 | Round, light purple, film-coated tablets debossed with “Pfizer” on one side and “PBC 75” on the other side. |
List of excipients
Capsules: Microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and hard gelatin capsule shells. The light orange, light orange/caramel and caramel opaque capsule shells contain gelatin, red iron oxide, yellow iron oxide, and titanium dioxide; and the printing ink contains shellac, titanium dioxide, ammonium hydroxide, propylene glycol and simethicone.
Tablets: Colloidal silicon dioxide, crospovidone, FD&C Blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide (in 75 mg and 125 mg tablets), succinic acid, titanium dioxide, triacetin and yellow iron oxide (in 100 mg tablet).
Control #: 243405
15 July 2021
IBRANCE (palbociclib) is supplied in the following strengths and package configurations:
| IBRANCE Capsules / Tablets | ||
|---|---|---|
| Package Configuration | Capsule / Tablet Strength (mg) | Dosage Form Description |
| Bottles of 21 capsules | 125 | opaque, hard gelatin capsules, size 0, with caramel cap and body, printed with white ink “Pfizer” on the cap, “PBC 125” on the body |
| Bottles of 21 capsules | 100 | opaque, hard gelatin capsules, size 1, with caramel cap and light orange body, printed with white ink “Pfizer” on the cap, “PBC 100” on the body |
| Bottles of 21 capsules | 75 | opaque, hard gelatin capsules, size 2, with light orange cap and body, printed with white ink “Pfizer” on the cap, “PBC 75” on the body |
| Box containing 3 weekly blister packs of 7 tablets each (21 tablets total) | 125 | Oval, light purple, film-coated tablets debossed with “Pfizer” on one side and “PBC 125” on the other side. |
| Box containing 3 weekly blister packs of 7 tablets each (21 tablets total) | 100 | Oval, green, film-coated tablets debossed with “Pfizer” on one side and “PBC 100” on the other side. |
| Box containing 3 weekly blister packs of 7 tablets each (21 tablets total) | 75 | Round, light purple, film-coated tablets debossed with “Pfizer” on one side and “PBC 75” on the other side. |
List of excipients
Capsules: Microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and hard gelatin capsule shells. The light orange, light orange/caramel and caramel opaque capsule shells contain gelatin, red iron oxide, yellow iron oxide, and titanium dioxide; and the printing ink contains shellac, titanium dioxide, ammonium hydroxide, propylene glycol and simethicone.
Tablets: Colloidal silicon dioxide, crospovidone, FD&C Blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide (in 75 mg and 125 mg tablets), succinic acid, titanium dioxide, triacetin and yellow iron oxide (in 100 mg tablet).
Control #: 243405
15 July 2021
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