Prescription Drug Information: Talzenna (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 0.25 mg Capsule Bottle Label

Pfizer

NDC 0069-0296-30

Talzenna™
(talazoparib) capsules

0.25 mg

30 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 0.25 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25 mg Capsule Bottle Carton

Pfizer

NDC 0069-0296-30

Talzenna™
(talazoparib)
capsules

0.25 mg

30 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 0.25 Capsule Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mg Capsule Bottle Label

Pfizer

NDC 0069-1195-30

Talzenna™
(talazoparib) capsules

1 mg

30 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 1 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mg Capsule Bottle Carton

Pfizer

NDC 0069-1195-30

Talzenna™
(talazoparib)
capsules

1 mg

30 CapsulesRx only

PRINCIPAL DISPLAY PANEL -- 1 mg Capsule Bottle Carton
(click image for full-size original)
TALZENNA talazoparib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0296
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TALAZOPARIB TOSYLATE (TALAZOPARIB) TALAZOPARIB 0.25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
TITANIUM DIOXIDE
SHELLAC
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
AMMONIA
PROPYLENE GLYCOL, (R)-
Product Characteristics
Color WHITE (ivory cap) , WHITE (white body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Pfizer;TLZ;025
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0296-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211651 10/26/2018
TALZENNA talazoparib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-1195
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TALAZOPARIB TOSYLATE (TALAZOPARIB) TALAZOPARIB 1 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
TITANIUM DIOXIDE
SHELLAC
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
AMMONIA
PROPYLENE GLYCOL, (R)-
Product Characteristics
Color RED (light red cap) , WHITE (white body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Pfizer;TLZ;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-1195-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211651 10/26/2018
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 LABEL (0069-0296), LABEL (0069-1195), PACK (0069-0296), PACK (0069-1195)
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company LLC 618054084 LABEL (0069-0296), LABEL (0069-1195), PACK (0069-0296), PACK (0069-1195)

Revised: 03/2020 Pfizer Laboratories Div Pfizer Inc

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