Bortezomib For Injection, For Subcutaneous Or Intravenous Use

Bortezomib For Injection, For Subcutaneous Or Intravenous Use
SPL v1
SPL
SPL Set ID 582c7c0d-fa25-4586-8157-a1e2653d72d9
Routes
INTRAVENOUS SUBCUTANEOUS
Published
Effective Date 2022-05-05
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bortezomib (1 mg)
Inactive Ingredients
Mannitol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-05-02
Description

NDC 70771-1708-1 Bortezomib for Injection 3.5 mg/vial For Intravenous or Subcutaneous Use One Single-dose Vial Rx only 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 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

Medication Information

Description

NDC 70771-1708-1 Bortezomib for Injection 3.5 mg/vial For Intravenous or Subcutaneous Use One Single-dose Vial Rx only 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 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

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

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

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

Structured Label Content

Package Label.principal Display Panel (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

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:36:52.836181 · Updated: 2026-03-14T21:47:49.715958