NDC 58657-488

Urea 47

Urea

Urea 47 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 ID58657-488_0144cdaa-a95c-465f-a457-41b5a78c87a6
NDC58657-488
Product TypeHuman Prescription Drug
Proprietary NameUrea 47
Generic NameUrea
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-08-03
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameMethod Pharmaceuticals, LLC
Substance NameUREA
Active Ingredient Strength470 mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58657-488-05

142 g in 1 BOTTLE (58657-488-05)
Marketing Start Date2018-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58657-488-05 [58657048805]

Urea 47 CREAM
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-08-03
Marketing End Date2020-02-29
Inactivation Date2020-01-31
Reactivation Date2020-02-17

Drug Details

Active Ingredients

IngredientStrength
UREA470 mg/g

OpenFDA Data

SPL SET ID:09dc828d-92c3-4ca5-924e-af425b0cdf2b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1494097
  • NDC Crossover Matching brand name "Urea 47" or generic name "Urea"

    NDCBrand NameGeneric Name
    58657-488Urea 47Urea 47
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.