NDC 0069-0187

Ibrance

Palbociclib

Ibrance is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Palbociclib.

Product ID0069-0187_54fa32a8-a9aa-4643-a227-ddf95ec4dd05
NDC0069-0187
Product TypeHuman Prescription Drug
Proprietary NameIbrance
Generic NamePalbociclib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-02-03
Marketing CategoryNDA / NDA
Application NumberNDA207103
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NamePALBOCICLIB
Active Ingredient Strength75 mg/1
Pharm ClassesKinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0069-0187-21

21 CAPSULE in 1 BOTTLE (0069-0187-21)
Marketing Start Date2015-02-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-0187-21 [00069018721]

Ibrance CAPSULE
Marketing CategoryNDA
Application NumberNDA207103
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-03

Drug Details

Active Ingredients

IngredientStrength
PALBOCICLIB75 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"

NDCBrand NameGeneric Name
0069-0187Ibrancepalbociclib
0069-0188Ibrancepalbociclib
0069-0189Ibrancepalbociclib
0069-0284Ibrancepalbociclib
0069-0486Ibrancepalbociclib
0069-0688Ibrancepalbociclib
63539-187Ibrancepalbociclib
63539-188Ibrancepalbociclib
63539-189Ibrancepalbociclib
63539-284Ibrancepalbociclib
63539-486Ibrancepalbociclib
63539-688Ibrancepalbociclib

Trademark Results [Ibrance]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IBRANCE
IBRANCE
86314613 4928206 Live/Registered
Pfizer Inc.
2014-06-19
IBRANCE
IBRANCE
85444239 4518147 Live/Registered
Pfizer Inc.
2011-10-11
IBRANCE
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.