NDC 44523-617

UREA

Urea

UREA is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Biocomp Pharma, Inc.. The primary component is Urea.

Product ID44523-617_6774a5ef-9bb1-4e7a-e053-2a91aa0af47f
NDC44523-617
Product TypeHuman Prescription Drug
Proprietary NameUREA
Generic NameUrea
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-03-15
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameBioComp Pharma, Inc.
Substance NameUREA
Active Ingredient Strength400 mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 44523-617-01

1 BOTTLE, PLASTIC in 1 CARTON (44523-617-01) > 28.35 g in 1 BOTTLE, PLASTIC
Marketing Start Date2018-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 44523-617-07 [44523061707]

UREA CREAM
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-03-15
Inactivation Date2020-01-31
Reactivation Date2020-04-28

NDC 44523-617-03 [44523061703]

UREA CREAM
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-03-15
Inactivation Date2020-01-31
Reactivation Date2020-04-28

NDC 44523-617-01 [44523061701]

UREA CREAM
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-03-15
Inactivation Date2020-01-31
Reactivation Date2020-04-28

Drug Details

Active Ingredients

IngredientStrength
UREA400 mg/g

OpenFDA Data

SPL SET ID:6774a5ef-9bb0-4e7a-e053-2a91aa0af47f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198342
  • UPC Code
  • 0344523617018
  • 0344523617070
  • 0344523617032
  • 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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