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 prescription medication containing tacrolimus that helps prevent organ rejection in transplant patients by suppressing the immune system. It is taken by mouth as an extended-release capsule, which means it releases the medication slowly over time.

Key Facts

Brand Name
ASTAGRAF XL
Generic Name
tacrolimus extended-release capsules
NDC Code (Product)
0469-0687
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

Frequently Asked Questions

What is ASTAGRAF XL used for?

Astagraf XL is a prescription medication containing tacrolimus that helps prevent organ rejection in transplant patients by suppressing the immune system. It is taken by mouth as an extended-release capsule, which means it releases the medication slowly over time.

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 0469-0687, listed by Astellas Pharma US, Inc..

Product NDC

0469-0687

Package NDC

0469-0687-73

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

Data from openFDA · Public domain (CC0 1.0)