NDC 70518-2292

pimecrolimus

Pimecrolimus

pimecrolimus is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Pimecrolimus.

Product ID70518-2292_9228a39b-38d5-1dfc-e053-2a95a90a3c90
NDC70518-2292
Product TypeHuman Prescription Drug
Proprietary Namepimecrolimus
Generic NamePimecrolimus
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-09-03
Marketing CategoryANDA / ANDA
Application NumberANDA209345
Labeler NameREMEDYREPACK INC.
Substance NamePIMECROLIMUS
Active Ingredient Strength10 mg/g
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2292-0

30 g in 1 TUBE (70518-2292-0)
Marketing Start Date2019-09-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2292-0 [70518229200]

pimecrolimus CREAM
Marketing CategoryANDA
Application NumberANDA209345
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-03

Drug Details

Active Ingredients

IngredientStrength
PIMECROLIMUS10 mg/g

OpenFDA Data

SPL SET ID:802a1ab4-690f-47bd-b1f3-f20a7a04978b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 562806

    • Pharmacological Class

    • Calcineurin Inhibitor Immunosuppressant [EPC]
    • Calcineurin Inhibitors [MoA]
    • Calcineurin Inhibitor Immunosuppressant [EPC]
    • Calcineurin Inhibitors [MoA]

    NDC Crossover Matching brand name "pimecrolimus" or generic name "Pimecrolimus"

    NDCBrand NameGeneric Name
    0591-2944pimecrolimuspimecrolimus
    68462-609PimecrolimusPimecrolimus
    68682-110PimecrolimusPimecrolimus
    68682-111PimecrolimusPimecrolimus
    68682-112PimecrolimusPimecrolimus
    70518-2292pimecrolimuspimecrolimus
    0187-5100ELIDELPimecrolimus
    0187-5101ELIDELPimecrolimus
    0187-5102ELIDELPimecrolimus
    0187-5103ELIDELPimecrolimus
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