Ibrance

Product NDC
0069-0187
11-digit product format
000690187
Labeler code
0069
Product ID
0069-0187_fb858b80-8bd4-43a6-8871-9819a35ca03f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
palbociclib
Dosage form
CAPSULE
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA207103
Marketing category
NDA
Marketing start
2015-02-03
Marketing end
2029-03-31
Substance
PALBOCICLIB
Active strength
75 mg/1
Pharmacologic classes
Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibrance

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PALBOCICLIB75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG9ZF61LE7G
Rxcui1601380, 1601386, 1601388, 1601390, 1601392, 1601394

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c1f85e95-ece0-4b26-a786-e9ff64eb69dcProduct name120200415
5a4db755-de93-485c-89bf-cac499b46d8cProduct name220160328

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0187-21Ibrance21 in 1 BOTTLECAPSULE2121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0187-21EA - Each0069-0187796becb2-3f32-4fa7-9071-d5975430461712015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PALBOCICLIBACTIVE INGREDIENTG9ZF61LE7GIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
PALBOCICLIBACTIVE MOIETYG9ZF61LE7GIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
GELATININACTIVE INGREDIENT2G86QN327LIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
SHELLACINACTIVE INGREDIENT46N107B71OIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0187IBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]18Current NDC, Legacy NDC, 1 package rows20250507_e0e6412f-50b4-4fd4-9364-62818d121a07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601386Ibrance 100 MG Oral CapsulePSNe0e6412f-50b4-4fd4-9364-62818d121a0721
1601390Ibrance 125 MG Oral CapsulePSNe0e6412f-50b4-4fd4-9364-62818d121a0721
1601394Ibrance 75 MG Oral CapsulePSNe0e6412f-50b4-4fd4-9364-62818d121a0721
1601380palbociclib 100 MG Oral CapsulePSNe0e6412f-50b4-4fd4-9364-62818d121a0721
1601388palbociclib 125 MG Oral CapsulePSNe0e6412f-50b4-4fd4-9364-62818d121a0721
1601392palbociclib 75 MG Oral CapsulePSNe0e6412f-50b4-4fd4-9364-62818d121a0721
1601386palbociclib 100 MG Oral Capsule [Ibrance]SBDe0e6412f-50b4-4fd4-9364-62818d121a0721
1601390palbociclib 125 MG Oral Capsule [Ibrance]SBDe0e6412f-50b4-4fd4-9364-62818d121a0721
1601394palbociclib 75 MG Oral Capsule [Ibrance]SBDe0e6412f-50b4-4fd4-9364-62818d121a0721
1601380palbociclib 100 MG Oral CapsuleSCDe0e6412f-50b4-4fd4-9364-62818d121a0721
1601388palbociclib 125 MG Oral CapsuleSCDe0e6412f-50b4-4fd4-9364-62818d121a0721
1601392palbociclib 75 MG Oral CapsuleSCDe0e6412f-50b4-4fd4-9364-62818d121a0721
1601386Ibrance 100 MG Oral CapsuleSYe0e6412f-50b4-4fd4-9364-62818d121a0721
1601390Ibrance 125 MG Oral CapsuleSYe0e6412f-50b4-4fd4-9364-62818d121a0721
1601394Ibrance 75 MG Oral CapsuleSYe0e6412f-50b4-4fd4-9364-62818d121a0721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-0187-210006901872121 CAPSULE in 1 BOTTLE (0069-0187-21) 21 capsule2015-02-030000-00-00NoNoCurrent