NDC 68682-112

Pimecrolimus

Pimecrolimus

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

Product ID68682-112_40053491-d587-4bf0-92fc-13d3a035552e
NDC68682-112
Product TypeHuman Prescription Drug
Proprietary NamePimecrolimus
Generic NamePimecrolimus
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-11-26
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021302
Labeler NameOceanside Pharmaceuticals
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 68682-112-03

1 TUBE in 1 CARTON (68682-112-03) > 100 g in 1 TUBE
Marketing Start Date2018-11-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68682-112-03 [68682011203]

Pimecrolimus CREAM
Marketing CategoryNDA authorized generic
Application NumberNDA021302
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-11-26

Drug Details

Active Ingredients

IngredientStrength
PIMECROLIMUS10 mg/g

OpenFDA Data

SPL SET ID:6601e43e-ce7d-446a-8568-8e7b24b86f06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 562806
  • Pharmacological Class

    • 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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