Enoxaparin Sodium Injection, For Subcutaneous And Intravenous Use

Enoxaparin Sodium Injection, For Subcutaneous And Intravenous Use
SPL v2
SPL
SPL Set ID b4d9e4d4-4fdb-48d6-a169-7bc5eebc51e9
Routes
INTRAVENOUS SUBCUTANEOUS
Published
Effective Date 2021-03-30
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Enoxaparin (30 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-04-01

Description

NDC 11797-757-06 Enoxaparin Sodium Injection USP 30 mg/0.3 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.3 mL Syringes NDC 11797-758-06 Enoxaparin Sodium Injection USP 40 mg/0.4 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.4 mL Syringes NDC 11797-759-06 Enoxaparin Sodium Injection USP 60 mg/0.6 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.6 mL Syringes NDC 11797-760-06 Enoxaparin Sodium Injection USP 80 mg/0.8 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.8 mL Syringes NDC 11797-761-06 Enoxaparin Sodium Injection USP 100 mg/1 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 1 mL Syringes NDC 11797-762-06 Enoxaparin Sodium Injection USP 120 mg/0.8 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.8 mL Syringes NDC 11797-763-06 Enoxaparin Sodium Injection USP 150 mg/1 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 1 mL Syringes


Medication Information

Description

NDC 11797-757-06 Enoxaparin Sodium Injection USP 30 mg/0.3 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.3 mL Syringes NDC 11797-758-06 Enoxaparin Sodium Injection USP 40 mg/0.4 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.4 mL Syringes NDC 11797-759-06 Enoxaparin Sodium Injection USP 60 mg/0.6 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.6 mL Syringes NDC 11797-760-06 Enoxaparin Sodium Injection USP 80 mg/0.8 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.8 mL Syringes NDC 11797-761-06 Enoxaparin Sodium Injection USP 100 mg/1 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 1 mL Syringes NDC 11797-762-06 Enoxaparin Sodium Injection USP 120 mg/0.8 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 0.8 mL Syringes NDC 11797-763-06 Enoxaparin Sodium Injection USP 150 mg/1 mL SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE FOR SUBCUTANEOUS INJECTION Ten 1 mL Syringes

Package Label.principal Display Panel

NDC 11797-757-06

Enoxaparin Sodium Injection USP

30 mg/0.3 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.3 mL Syringes

NDC 11797-758-06

Enoxaparin Sodium Injection USP

40 mg/0.4 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.4 mL Syringes

NDC 11797-759-06

Enoxaparin Sodium Injection USP

60 mg/0.6 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.6 mL Syringes

NDC 11797-760-06

Enoxaparin Sodium Injection USP

80 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

NDC 11797-761-06

Enoxaparin Sodium Injection USP

100 mg/1 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes

NDC 11797-762-06

Enoxaparin Sodium Injection USP

120 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

NDC 11797-763-06

Enoxaparin Sodium Injection USP

150 mg/1 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes


Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 11797-757-06

Enoxaparin Sodium Injection USP

30 mg/0.3 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.3 mL Syringes

NDC 11797-758-06

Enoxaparin Sodium Injection USP

40 mg/0.4 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.4 mL Syringes

NDC 11797-759-06

Enoxaparin Sodium Injection USP

60 mg/0.6 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.6 mL Syringes

NDC 11797-760-06

Enoxaparin Sodium Injection USP

80 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

NDC 11797-761-06

Enoxaparin Sodium Injection USP

100 mg/1 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes

NDC 11797-762-06

Enoxaparin Sodium Injection USP

120 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

NDC 11797-763-06

Enoxaparin Sodium Injection USP

150 mg/1 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes


Advanced Ingredient Data


Raw Label Data

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