NDC 71399-4528

UREA

Urea

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

Product ID71399-4528_c4507c3a-556e-4145-a303-f6623f050901
NDC71399-4528
Product TypeHuman Prescription Drug
Proprietary NameUREA
Generic NameUrea
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-03-22
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameAKRON PHARMA INC
Substance NameUREA
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71399-4528-1

1 BOTTLE, GLASS in 1 CARTON (71399-4528-1) > 28 mL in 1 BOTTLE, GLASS
Marketing Start Date2019-03-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71399-4528-1 [71399452801]

UREA GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-22

Drug Details

Active Ingredients

IngredientStrength
UREA.45 mg/mL

OpenFDA Data

SPL SET ID:4b940ed8-4da4-47b4-8e24-29de9f0774b3
Manufacturer
UNII

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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