TALZENNA How Supplied/Storage and Handling

(talazoparib)

16 HOW SUPPLIED/STORAGE AND HANDLING

TALZENNA is supplied in strengths and package configurations as described in Table 12:

Table 12. TALZENNA Capsules

Package Configuration

Capsule Strength (mg)

NDC

Print

Bottles of 30 capsules

0.1

NDC 0069-1031-30

White cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.1” in black).

Bottles of 30 capsules

0.25

NDC 0069-0296-30

Ivory cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.25" in black).

Bottles of 30 capsules

0.35

NDC 0069-1235-30

Ivory cap (printed with “Pfizer” in black) and an ivory body (printed with “TLZ 0.35” in black).

Bottles of 30 capsules

0.5

NDC 0069-1501-30

Light pink cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.5" in black).

Bottles of 30 capsules

0.75

NDC 0069-1751-30

Light orange cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.75" in black).

Bottles of 30 capsules

1

NDC 0069-1195-30

Light red cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 1" in black).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

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Health Professional Information

How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

TALZENNA is supplied in strengths and package configurations as described in Table 12:

Table 12. TALZENNA Capsules

Package Configuration

Capsule Strength (mg)

NDC

Print

Bottles of 30 capsules

0.1

NDC 0069-1031-30

White cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.1” in black).

Bottles of 30 capsules

0.25

NDC 0069-0296-30

Ivory cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.25" in black).

Bottles of 30 capsules

0.35

NDC 0069-1235-30

Ivory cap (printed with “Pfizer” in black) and an ivory body (printed with “TLZ 0.35” in black).

Bottles of 30 capsules

0.5

NDC 0069-1501-30

Light pink cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.5" in black).

Bottles of 30 capsules

0.75

NDC 0069-1751-30

Light orange cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.75" in black).

Bottles of 30 capsules

1

NDC 0069-1195-30

Light red cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 1" in black).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Prescribing Information
Download Prescribing Information

Health Professional Information

How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

TALZENNA is supplied in strengths and package configurations as described in Table 12:

Table 12. TALZENNA Capsules

Package Configuration

Capsule Strength (mg)

NDC

Print

Bottles of 30 capsules

0.1

NDC 0069-1031-30

White cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.1” in black).

Bottles of 30 capsules

0.25

NDC 0069-0296-30

Ivory cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.25" in black).

Bottles of 30 capsules

0.35

NDC 0069-1235-30

Ivory cap (printed with “Pfizer” in black) and an ivory body (printed with “TLZ 0.35” in black).

Bottles of 30 capsules

0.5

NDC 0069-1501-30

Light pink cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.5" in black).

Bottles of 30 capsules

0.75

NDC 0069-1751-30

Light orange cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.75" in black).

Bottles of 30 capsules

1

NDC 0069-1195-30

Light red cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 1" in black).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

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FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.