NDC 0682-0051

Crotan

Crotamiton

Crotan is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Marnel Pharmaceuticals, Inc.. The primary component is Crotamiton.

Product ID0682-0051_9d369d3e-fa64-8bf5-e053-2a95a90a1212
NDC0682-0051
Product TypeHuman Prescription Drug
Proprietary NameCrotan
Generic NameCrotamiton
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-07-16
Marketing CategoryANDA / ANDA
Application NumberANDA087204
Labeler NameMarnel Pharmaceuticals, Inc.
Substance NameCROTAMITON
Active Ingredient Strength100 mg/g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0682-0051-10

237 g in 1 BOTTLE, PLASTIC (0682-0051-10)
Marketing Start Date2018-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0682-0051-10 [00682005110]

Crotan LOTION
Marketing CategoryANDA
Application NumberANDA087204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-07-16

NDC 0682-0051-30 [00682005130]

Crotan LOTION
Marketing CategoryANDA
Application NumberANDA087204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-08-13

NDC 0682-0051-20 [00682005120]

Crotan LOTION
Marketing CategoryANDA
Application NumberANDA087204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-08-13

Drug Details

Active Ingredients

IngredientStrength
CROTAMITON100 mg/g

OpenFDA Data

SPL SET ID:6f7478fa-ed2b-4943-9d40-1fd0161a0854
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 106219
  • 2049603
  • NDC Crossover Matching brand name "Crotan" or generic name "Crotamiton"

    NDCBrand NameGeneric Name
    0682-0051CrotanCrotamiton
    10631-091Euraxcrotamiton
    10631-092Euraxcrotamiton

    Trademark Results [Crotan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CROTAN
    CROTAN
    87736767 5630930 Live/Registered
    Estrat Inc.
    2017-12-28
    CROTAN
    CROTAN
    86207595 not registered Dead/Abandoned
    Summers Laboratories, Inc.
    2014-02-28
    CROTAN
    CROTAN
    85096647 not registered Dead/Abandoned
    Summers Laboratories, Inc.
    2010-07-30
    CROTAN
    CROTAN
    78902471 not registered Dead/Abandoned
    Summers Laboratories, Inc.
    2006-06-07

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