NDC 58657-485

MeTopic

Urea

MeTopic is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Method Pharmaceuticals, Llc. The primary component is Urea.

Product ID58657-485_2fcf6663-20b9-4432-9e3c-3ea44912a824
NDC58657-485
Product TypeHuman Prescription Drug
Proprietary NameMeTopic
Generic NameUrea
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-04-05
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameMethod Pharmaceuticals, LLC
Substance NameUREA
Active Ingredient Strength410 mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58657-485-08

227 g in 1 BOTTLE (58657-485-08)
Marketing Start Date2018-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58657-485-08 [58657048508]

MeTopic CREAM
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-04-05
Marketing End Date2020-02-10
Inactivation Date2020-01-31
Reactivation Date2020-02-17

Drug Details

Active Ingredients

IngredientStrength
UREA410 mg/g

OpenFDA Data

SPL SET ID:2072755e-1da3-4f8a-9b05-1a34610ad297
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1436933
  • NDC Crossover Matching brand name "MeTopic" or generic name "Urea"

    NDCBrand NameGeneric Name
    58657-485MeTopicMeTopic
    42546-100CEM-Ureaurea
    10481-3005GORDONS UREA 40UREA
    15631-0449UREAUREA
    42192-101UREAUREA
    42291-849UREAUREA
    42792-101UREAUREA
    42808-202UREAUREA
    42808-204UreaUrea
    44523-617UREAurea
    50268-872UREAUREA
    51862-181UreaUrea
    52187-549UREAUREA
    52191-351UreaUREA
    54295-308UREAUREA
    50268-820Urea 20Urea
    50096-501Urea 47% CreamUREA
    0904-7167Urea Cream 40%Urea
    16477-340Urea Cream 40%Urea
    16477-341Urea Cream 41%Urea
    42192-115UREA HYDRATING TOPICALUREA
    42361-043YouGreen FUrea

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