NDC 0187-5103

ELIDEL

Pimecrolimus

ELIDEL is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Pimecrolimus.

Product ID0187-5103_2f802a3f-c021-45c1-8693-5689c30c3fc6
NDC0187-5103
Product TypeHuman Prescription Drug
Proprietary NameELIDEL
Generic NamePimecrolimus
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2001-12-02
Marketing CategoryNDA / NDA
Application NumberNDA021302
Labeler NameBausch Health US, LLC
Substance NamePIMECROLIMUS
Active Ingredient Strength10 mg/g
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0187-5103-04

1 TUBE in 1 CARTON (0187-5103-04) > 5 g in 1 TUBE
Marketing Start Date2001-12-02
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 0187-5103-04 [00187510304]

ELIDEL CREAM
Marketing CategoryNDA
Application NumberNDA021302
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-12-02

Drug Details

Active Ingredients

IngredientStrength
PIMECROLIMUS10 mg/g

OpenFDA Data

SPL SET ID:e4027e5a-0f9b-4070-b196-f60172f45c4c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 352085
  • 562806
  • Pharmacological Class

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

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

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

    Trademark Results [ELIDEL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ELIDEL
    ELIDEL
    78526455 not registered Dead/Abandoned
    Novartis AG
    2004-12-03
    ELIDEL
    ELIDEL
    75104787 2442908 Live/Registered
    MEDA PHARMA S.A.R.L.
    1996-05-15

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