Lacosamide Injection
FDA Label NDC 70771-1682

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 Lacosamide (NDC 70771-1682). 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 70771-1682-1

Lacosamide Injection, USP 200 mg/20 mL (10 mg/mL); CV

For Intravenous Use Only

20 mL single-dose vial

Rx only

Vial Label (2e8b7789 C673 4f02 B73b Bd465c71c7f5 01)

Vial Label (2e8b7789 C673 4f02 B73b Bd465c71c7f5 01)

NDC 70771-1682-6

Lacosamide Injection, USP 200 mg/20 mL (10 mg/mL); CV

For Intravenous Use Only

10 X 20 mL Single-dose vials

Rx only

Carton Label (2e8b7789 C673 4f02 B73b Bd465c71c7f5 02)

Carton Label (2e8b7789 C673 4f02 B73b Bd465c71c7f5 02)

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