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NDC 54288-0135-01 Tacrolimus 1 mg/1 Details

Tacrolimus 1 mg/1

Tacrolimus is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BPI LABS LLC. The primary component is TACROLIMUS.

MedlinePlus Drug Summary

Tacrolimus (Astagraf XL, Envarsus XR, Prograf) is used along with other medications to prevent rejection (attack of a transplanted organ by the immune system of a person receiving the organ) in people who have received a kidney transplant. Tacrolimus (Prograf) is also used along with other medications to prevent rejection in people who have received a liver, lung, or heart transplant. Tacrolimus is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.

Related Packages: 54288-0135-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tacrolimus

Product Information

NDC	54288-0135
Product ID	54288-135_06f9676f-94da-ab74-e063-6394a90ae690
Associated GPIs	99404080000110
GCN Sequence Number	021796
GCN Sequence Number Description	tacrolimus CAPSULE 1 MG ORAL
HIC3	Z2E
HIC3 Description	IMMUNOSUPPRESSIVES
GCN	28491
HICL Sequence Number	020974
HICL Sequence Number Description	TACROLIMUS
Brand/Generic	Generic
Proprietary Name	Tacrolimus
Proprietary Name Suffix	n/a
Non-Proprietary Name	Tacrolimus
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	1
Active Ingredient Units	mg/1
Substance Name	TACROLIMUS
Labeler Name	BPI LABS LLC
Pharmaceutical Class	Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA206651
Listing Certified Through	2024-12-31

Package

NDC 54288-0135-01 (54288013501)

Pricing Information	N/A
NDC Package Code	54288-135-01
Billing NDC	54288013501
Package	100 CAPSULE in 1 BOTTLE (54288-135-01)
Marketing Start Date	2020-04-08
NDC Exclude Flag	N