Drugplain

ASTAGRAF XL .5 mg/1

tacrolimus extended-release capsules · CAPSULE, COATED, EXTENDED RELEASE · Astellas Pharma US, Inc.

1 Recall on Record
Plain English

ASTAGRAF XL is a capsule, coated, extended release containing tacrolimus extended-release capsules at .5 mg/1, taken oral. Manufactured by Astellas Pharma US, Inc..

Key Facts

Brand Name
ASTAGRAF XL
Generic Name
tacrolimus extended-release capsules
NDC Code (Product)
0469-0647
Manufacturer
Astellas Pharma US, Inc.
Strength
.5 mg/1
Dosage Form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA204096
Marketing Start
07/19/2013

Recall History

1 Recall on Record
Class I12/23/2024

Astellas Pharma US Inc.

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death27 reports
inappropriate schedule of drug administration20 reports
diarrhoea15 reports
hospitalisation15 reports
off label use15 reports
malaise13 reports
pneumonia13 reports
nausea11 reports
treatment noncompliance11 reports
kidney transplant rejection10 reports

Frequently Asked Questions

What is ASTAGRAF XL used for?

ASTAGRAF XL contains tacrolimus extended-release capsules. It is a capsule, coated, extended release taken oral. Consult your doctor for specific uses.

Is ASTAGRAF XL a controlled substance?

ASTAGRAF XL is not classified as a controlled substance by the DEA.

What is the generic name for ASTAGRAF XL?

The generic name for ASTAGRAF XL is tacrolimus extended-release capsules. There are 3 other brand versions of tacrolimus extended-release capsules.

What is the NDC code for ASTAGRAF XL .5 mg/1?

The NDC (National Drug Code) for ASTAGRAF XL .5 mg/1 is 0469-0647, listed by Astellas Pharma US, Inc..

Product NDC

0469-0647

Package NDC

0469-0647-73

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

Data from openFDA · Public domain (CC0 1.0)