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 ID0069-0284_42b1133b-b05f-49ef-8710-a29937753b54
NDC0069-0284
Product TypeHuman Prescription Drug
Proprietary NameIbrance
Generic NamePalbociclib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-03-30
Marketing CategoryNDA / NDA
Application NumberNDA212436
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NamePALBOCICLIB
Active Ingredient Strength75 mg/1
Pharm ClassesCytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

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 Date2020-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-0284-03 [00069028403]

Ibrance TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA212436
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-30

NDC 0069-0284-07 [00069028407]

Ibrance TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA212436
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-30

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.