NDC 57893-301

Utopic

Urea

Utopic is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Artesa Labs, Llc. The primary component is Urea.

• Product ID: 57893-301_7cedfd8f-2ac1-5db4-e053-2991aa0a9bac
• NDC: 57893-301
• Product Type: Human Prescription Drug
• Proprietary Name: Utopic
• Generic Name: Urea
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-08-15
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Artesa Labs, LLC
• Substance Name: UREA
• Active Ingredient Strength: 410 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57893-301-01

10 TUBE in 1 CARTON (57893-301-01) > 4 g in 1 TUBE (57893-301-04)

• Marketing Start Date: 2018-02-01
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 57893-301-08 [57893030108]

Utopic CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-08-15

NDC 57893-301-09 [57893030109]

Utopic CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-08-15
• Marketing End Date: 2020-01-31

NDC 57893-301-04 [57893030104]

Utopic CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-11

NDC 57893-301-01 [57893030101]

Utopic CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-02-01

Drug Details

Active Ingredients

Ingredient	Strength
UREA	410 mg/g

OpenFDA Data

• SPL SET ID: 150f46af-f08e-401a-88d1-2d855f04b2e5
• Manufacturer:
  • Artesa Labs, LLC
• UNII:
  • 8W8T17847W
• RxNorm Concept Unique ID - RxCUI:
  • 1436933
  • 1436938

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

NDC	Brand Name	Generic Name
57893-301	Utopic	Utopic
42546-100	CEM-Urea	urea
10481-3005	GORDONS UREA 40	UREA
15631-0449	UREA	UREA
42192-101	UREA	UREA
42291-849	UREA	UREA
42792-101	UREA	UREA
42808-202	UREA	UREA
42808-204	Urea	Urea
44523-617	UREA	urea
50268-872	UREA	UREA
51862-181	Urea	Urea
52187-549	UREA	UREA
52191-351	Urea	UREA
54295-308	UREA	UREA
50268-820	Urea 20	Urea
50096-501	Urea 47% Cream	UREA
0904-7167	Urea Cream 40%	Urea
16477-340	Urea Cream 40%	Urea
16477-341	Urea Cream 41%	Urea
42192-115	UREA HYDRATING TOPICAL	UREA
42361-043	YouGreen F	Urea