Bortezomib Injection, Powder, Lyophilized, For Solution
FDA Label NDC 70771-1708

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Bortezomib (NDC 70771-1708). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Package Label.Principal Display Panel

NDC 70771-1708-1

Bortezomib for Injection

3.5 mg/vial

For Intravenous or Subcutaneous Use

One Single-dose Vial

Rx only

Vial Label (A7ff2205 566b 4fb5 8f33 Bf73377ee093 01)

Vial Label (A7ff2205 566b 4fb5 8f33 Bf73377ee093 01)

NDC 70771-1708-1

Bortezomib for Injection – Carton label

3.5 mg/vial

For Intravenous or Subcutaneous Use

Reconstitution Information

SUBCUTANEOUS INJECTION ONLY

0.9% NaCl

Add

1.4 mL

0.9% Sodium Chloride

To make

2.5 mg/mL

final concentration

INTRAVENOUS INJECTION ONLY

0.9% NaCl

Add

3.5 mL

0.9% Sodium Chloride

To make

1 mg/mL

final concentration

One Single-dose Vial

Rx only

Carton Label (A7ff2205 566b 4fb5 8f33 Bf73377ee093 02)

Carton Label (A7ff2205 566b 4fb5 8f33 Bf73377ee093 02)

Reconstitution Information – Inside Flap (All cartons)

SUBCUTANEOUS INJECTION ONLY

0.9% NaCl

Add

1.4 mL

0.9% Sodium Chloride

To make

2.5 mg/mL

final concentration

INTRAVENOUS INJECTION ONLY

0.9% NaCl

Add

3.5 mL

0.9% Sodium Chloride

To make

1 mg/mL

final concentration

Inside Flap Image (A7ff2205 566b 4fb5 8f33 Bf73377ee093 03)

Inside Flap Image (A7ff2205 566b 4fb5 8f33 Bf73377ee093 03)

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