NDC 42808-204

Urea

Urea

Urea is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Exact-rx, Inc.. The primary component is Urea.

Product ID42808-204_7d508fdd-ba55-07ec-e053-2991aa0a29ef
NDC42808-204
Product TypeHuman Prescription Drug
Proprietary NameUrea
Generic NameUrea
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2011-08-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameExact-Rx, Inc.
Substance NameUREA
Active Ingredient Strength450 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42808-204-28

1 BOTTLE, GLASS in 1 CARTON (42808-204-28) > 28 mL in 1 BOTTLE, GLASS
Marketing Start Date2011-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42808-204-28 [42808020428]

Urea GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-08-01

Drug Details

Active Ingredients

IngredientStrength
UREA450 mg/mL

OpenFDA Data

SPL SET ID:b58e175d-60e8-4206-ac7a-c67b68ac80f0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 827406

    • NDC Crossover Matching brand name "Urea" or generic name "Urea"

    NDCBrand NameGeneric Name
    15631-0449UREAUREA
    42192-101UREAUREA
    42291-849UREAUREA
    42792-101UREAUREA
    42808-202UREAUREA
    42808-204UreaUrea
    44523-617UREAurea
    50268-872UREAUREA
    51862-181UreaUrea
    52187-549UREAUREA
    52191-351UreaUREA
    54295-308UREAUREA
    68428-688UreaUrea
    71399-4528UREAUREA
    54295-312UREAUREA
    54295-311UREAUREA
    71919-694UREAUREA
    63629-2040UREAUREA
    63629-2039UREAUREA
    63629-2036UREAUREA
    63629-2037UREAUREA
    63629-2038UREAUREA
    42546-100CEM-Ureaurea
    10481-3005GORDONS UREA 40UREA
    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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