NDC 42546-100

CEM-Urea

Urea

CEM-Urea is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Prugen, Inc.. The primary component is Urea.

• Product ID: 42546-100_2267e100-a474-4423-8f46-3458a9e5e221
• NDC: 42546-100
• Product Type: Human Prescription Drug
• Proprietary Name: CEM-Urea
• Generic Name: Urea
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-07-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: PruGen, Inc.
• Substance Name: UREA
• Active Ingredient Strength: 0 mL/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 42546-100-20

1 APPLICATOR in 1 BOX (42546-100-20) > 20 mL in 1 APPLICATOR

• Marketing Start Date: 2011-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42546-100-20 [42546010020]

CEM-Urea SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-07-01
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
UREA	.45 mL/mL

OpenFDA Data

• SPL SET ID: 697b1730-b716-444f-8671-934f47ae21bd
• Manufacturer:
  • PruGen, Inc.
• UNII:
  • 8W8T17847W
• RxNorm Concept Unique ID - RxCUI:
  • 1242631
  • 827406

NDC Crossover Matching brand name "CEM-Urea" or generic name "Urea"

NDC	Brand Name	Generic Name
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