Sugammadex Injection, Solution
FDA Label NDC 70771-1857

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 Sugammadex (NDC 70771-1857). 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 70771-1856-1

Sugammadex

Injection

200 mg/ 2 mL

(100 mg/mL) – Vial Label

For Intravenous Use Only

Storage: 25°C (77°F)

Protect from light

2 mL Single-Dose Vial

Discard unused portion

Rx only

Vial Label (A25a56d4 E46c 40ec A20e A31be11f91a1 01)

Vial Label (A25a56d4 E46c 40ec A20e A31be11f91a1 01)

NDC 70771-1857-1

Sugammadex

Injection

500 mg/5 mL

(100 mg/mL)

For Intravenous Use Only

Storage: 25°C (77°F)

Protect from light

5 mL Single-Dose Vial

Discard unused portion

Rx only

Vial Label (A25a56d4 E46c 40ec A20e A31be11f91a1 02)

Vial Label (A25a56d4 E46c 40ec A20e A31be11f91a1 02)

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