This site is intended for healthcare professionals
FDA Hero Banner - Multi-coloured pills and tablets
FDA Drug information

Mycophenolate Mofetil

Read time: 1 mins
Marketing start date: 08 May 2024
...
 

Summary of product characteristics


Effective Time

20231003

Version

7

Spl Product Data Elements

Mycophenolate Mofetil Mycophenolate Mofetil MYCOPHENOLATE MOFETIL MYCOPHENOLIC ACID POLYSORBATE 80 ANHYDROUS CITRIC ACID WATER HYDROCHLORIC ACID SODIUM HYDROXIDE

Application Number

ANDA204473

Brand Name

Mycophenolate Mofetil

Generic Name

Mycophenolate Mofetil

Product Ndc

70771-1084

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL – MYCOPHENOLATE MOFETIL 500 MG CONTAINER LABEL NDC 70771-1084-1 Mycophenolate Mofetil for Injection, USP (500 mg per Vial) FOR INTRAVENOUS INFUSION ONLY PHARMACIST: Dispense the Medication Guide provided separately to each patient. SINGLE DOSE VIAL Rx only Zydus Pharmaceuticals PRINCIPAL DISPLAY PANEL - MYCOPHENOLATE MOFETIL 500 MG CARTON LABEL NDC 70771-1084-8 Mycophenolate Mofetil for Injection, USP (500 mg per Vial) PHARMACIST: Dispense the Medication Guide provided separately to each patient. FOR INTRAVENOUS INFUSION ONLY SINGLE DOSE VIAL 4 Vials Rx only Zydus Pharmaceuticals Container Label Carton Label

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.