Enoxaparin Sodium Injection, Solution
FDA Label NDC 11797-759

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Italfarmaco Spa for the product Enoxaparin Sodium (NDC 11797-759). 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.

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

30 mg (C361399b 34e7 4807 8386 100d1383685f 01)

30 mg (C361399b 34e7 4807 8386 100d1383685f 01)

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

40 mg (C361399b 34e7 4807 8386 100d1383685f 02)

40 mg (C361399b 34e7 4807 8386 100d1383685f 02)

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

60 mg (C361399b 34e7 4807 8386 100d1383685f 03)

60 mg (C361399b 34e7 4807 8386 100d1383685f 03)

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

80 mg (C361399b 34e7 4807 8386 100d1383685f 04)

80 mg (C361399b 34e7 4807 8386 100d1383685f 04)

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

100 mg (C361399b 34e7 4807 8386 100d1383685f 05)

100 mg (C361399b 34e7 4807 8386 100d1383685f 05)

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

120 mg (C361399b 34e7 4807 8386 100d1383685f 06)

120 mg (C361399b 34e7 4807 8386 100d1383685f 06)

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

150 mg (C361399b 34e7 4807 8386 100d1383685f 07)

150 mg (C361399b 34e7 4807 8386 100d1383685f 07)

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