Romidepsin Kit
FDA Label NDC 70771-1986

1 label section · Submitted to the FDA by Zydus Lifesciences Limited · 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 Romidepsin (NDC 70771-1986). 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

Romidepsin for Injection,10 mg/vial

NDC 70771-1984-1

For Intravenous Use Only.

Product MUST be reconstituted with 2.2 mL of supplied diluent for a concentration of 5 mg/mL and then further diluted in 500 mL of 0.9% sodium chloride Injection, USP.

Single-Dose Vial

Discard unused portion

Sterile

Rx only

Label (4dea32df 60fe 4f7b 8a94 45266b13553e 01)

Label (4dea32df 60fe 4f7b 8a94 45266b13553e 01)

Diluent for Romidepsin for Injection

2.2 mL per single dose vial 

NDC 70710-2182-1

For Intravenous Use Only.

Single-Dose Vial

Discard unused portion

Sterile

Rx only

Zydus

Diluent Label (4dea32df 60fe 4f7b 8a94 45266b13553e 02)

Diluent Label (4dea32df 60fe 4f7b 8a94 45266b13553e 02)

Romidepsin for injection Kit

NDC 70771-1986-3

For Intravenous Use Only.

Reconstitution and dilution required.

Each kit contains:

- One 10 mg single-dose vial of romidepsin for injection

- One single-dose vial with 2.2 mL of diluent

Single-Dose Vial

Discard unused portion

Sterile

Rx only

Kit Label (4dea32df 60fe 4f7b 8a94 45266b13553e 03)

Kit Label (4dea32df 60fe 4f7b 8a94 45266b13553e 03)

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