NDC 0299-3823

SOOLANTRA

Ivermectin

SOOLANTRA is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Ivermectin.

Product ID0299-3823_0e84e7ac-c8f4-40b5-917f-6dbfb22a046c
NDC0299-3823
Product TypeHuman Prescription Drug
Proprietary NameSOOLANTRA
Generic NameIvermectin
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2015-01-01
Marketing CategoryNDA / NDA
Application NumberNDA206255
Labeler NameGalderma Laboratories, L.P.
Substance NameIVERMECTIN
Active Ingredient Strength10 mg/g
Pharm ClassesAntiparasitic [EPC], Pediculicide [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0299-3823-00

2 g in 1 TUBE (0299-3823-00)
Marketing Start Date2019-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0299-3823-02 [00299382302]

SOOLANTRA CREAM
Marketing CategoryNDA
Application NumberNDA206255
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-01

NDC 0299-3823-60 [00299382360]

SOOLANTRA CREAM
Marketing CategoryNDA
Application NumberNDA206255
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-01

NDC 0299-3823-00 [00299382300]

SOOLANTRA CREAM
Marketing CategoryNDA
Application NumberNDA206255
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-01

NDC 0299-3823-45 [00299382345]

SOOLANTRA CREAM
Marketing CategoryNDA
Application NumberNDA206255
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-01-01

NDC 0299-3823-30 [00299382330]

SOOLANTRA CREAM
Marketing CategoryNDA
Application NumberNDA206255
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
IVERMECTIN10 mg/g

OpenFDA Data

SPL SET ID:b1d5b166-ab06-4ab5-b0c6-31126238118a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1598068
  • 1598073

    • Pharmacological Class

    • Antiparasitic [EPC]
    • Pediculicide [EPC]

    NDC Crossover Matching brand name "SOOLANTRA" or generic name "Ivermectin"

    NDCBrand NameGeneric Name
    0299-3823SOOLANTRAIVERMECTIN
    0363-4230IvermectinIvermectin
    0574-2107IvermectinIVERMECTIN
    0591-4052IvermectinIvermectin
    11822-4230IvermectinIvermectin
    42799-806IvermectinIvermectin
    50090-5587IvermectinIvermectin
    51316-423IvermectinIvermectin
    51672-4211IvermectinIvermectin
    51672-4230IvermectinIvermectin
    63629-7275IvermectinIvermectin
    63629-8754IvermectinIvermectin
    66993-948IvermectinIVERMECTIN
    68071-2242IvermectinIvermectin
    76413-155IvermectinIvermectin
    79903-154IvermectinIvermectin
    24338-183SkliceIVERMECTIN
    24338-185Skliceivermectin
    0006-0032STROMECTOLivermectin
    55695-019STROMECTOLivermectin

    Trademark Results [SOOLANTRA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOOLANTRA
    SOOLANTRA
    85836047 4490439 Live/Registered
    NESTLÉ SKIN HEALTH S.A.
    2013-01-30
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