Drugplain

CLOFARABINE 1 mg/mL

clofarabine · INJECTION · Zydus Lifesciences Limited

2 Recalls on Record
Plain English

CLOFARABINE is a injection containing clofarabine at 1 mg/mL, taken intravenous. Manufactured by Zydus Lifesciences Limited.

Key Facts

Brand Name
CLOFARABINE
Generic Name
clofarabine
NDC Code (Product)
49315-003
Manufacturer
Zydus Lifesciences Limited
Strength
1 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA204029
Drug Class
Nucleoside Metabolic Inhibitor [EPC]
Marketing Start
05/10/2017

Recall History

2 Recalls on Record
Class III10/13/2017

Sanofi-Aventis U.S. LLC

Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.

TerminatedVoluntary: Firm initiated
Class III10/12/2017

Genzyme Corporation

Labeling: Incorrect or Missing Package Insert.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is CLOFARABINE used for?

CLOFARABINE contains clofarabine. It is a injection taken intravenous. Consult your doctor for specific uses.

Is CLOFARABINE a controlled substance?

CLOFARABINE is not classified as a controlled substance by the DEA.

What is the generic name for CLOFARABINE?

The generic name for CLOFARABINE is clofarabine. There are 5 other brand versions of clofarabine.

What is the NDC code for CLOFARABINE 1 mg/mL?

The NDC (National Drug Code) for CLOFARABINE 1 mg/mL is 49315-003, listed by Zydus Lifesciences Limited.

Product NDC

49315-003

Package NDC

49315-003-06

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)