pimecrolimus
pimecrolimus is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including pimecrolimus. Available dosage forms: cream, powder.
Drug Details
- Generic Name
- pimecrolimus
- Brand Names
- pimecrolimus
- Application Number
- ANDA209345
- Sponsor
- Actavis Pharma, Inc.
- NDC Codes
- 2
- Dosage Forms
- CREAM, POWDER
- Routes
- TOPICAL
- Active Ingredients
- PIMECROLIMUS
Indications and Usage
1 INDICATIONS AND USAGE Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . Pimecrolimus Cream, 1% is a calcineurin inhibitor immunosuppressant indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ( 1 )