Tacrolimus (Page 6 of 6)

PRINCIPLE DISPLAY PANEL FOR TACROLIMUS OINTMENT 0.03%

NDC 45802-390-00

Rx only

Tacrolimus Ointment 0.03%

30 g

Attention: Dispense with enclosed Medication Guide

carton 30g 003
(click image for full-size original)

PRINCIPLE DISPLAY PANEL FOR TACROLIMUS OINTMENT 0.1%

NDC 45802-700-00

Rx only

Tacrolimus Ointment 0.1%

30 g

Attention: Dispense with enclosed Medication Guide

carton 30g 01
(click image for full-size original)
TACROLIMUS
tacrolimus ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-390
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 0.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PARAFFIN
PROPYLENE CARBONATE
PETROLATUM
WHITE WAX
.ALPHA.-TOCOPHEROL, DL-
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-390-00 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (45802-390-00)
2 NDC:45802-390-01 1 TUBE in 1 CARTON contains a TUBE
2 60 g in 1 TUBE This package is contained within the CARTON (45802-390-01)
3 NDC:45802-390-02 1 TUBE in 1 CARTON contains a TUBE
3 100 g in 1 TUBE This package is contained within the CARTON (45802-390-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050777 11/20/2014
TACROLIMUS
tacrolimus ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-700
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PARAFFIN
PROPYLENE CARBONATE
PETROLATUM
WHITE WAX
.ALPHA.-TOCOPHEROL, DL-
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-700-00 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (45802-700-00)
2 NDC:45802-700-01 1 TUBE in 1 CARTON contains a TUBE
2 60 g in 1 TUBE This package is contained within the CARTON (45802-700-01)
3 NDC:45802-700-02 1 TUBE in 1 CARTON contains a TUBE
3 100 g in 1 TUBE This package is contained within the CARTON (45802-700-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050777 11/20/2014
Labeler — Perrigo New York Inc (078846912)
Registrant — LEO Pharma, Inc. (832692615)

Revised: 05/2019 Perrigo New York Inc

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.