NDC 57883-401
Keralac
Urea
Keralac is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Brava Pharmaceuticals, Llc. The primary component is Urea.
| Product ID | 57883-401_7cfd83dc-9b9d-3645-e053-2a91aa0ab88c |
| NDC | 57883-401 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Keralac |
| Generic Name | Urea |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2011-07-01 |
| Marketing Category | UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER |
| Labeler Name | Brava Pharmaceuticals, LLC |
| Substance Name | UREA |
| Active Ingredient Strength | 470 mg/g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 57883-401-04
10 TUBE in 1 CARTON (57883-401-04) > 4 g in 1 TUBE
| Marketing Start Date | 2017-09-22 |
| NDC Exclude Flag | N |
| Sample Package? | Y |
NDC SPL Data Element Entries
NDC 57883-401-10 [57883040110]
Keralac CREAM
| Marketing Category | unapproved drug other |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Marketing End Date | 2020-08-31 |
NDC 57883-401-04 [57883040104]
Keralac CREAM
| Marketing Category | unapproved drug other |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-09-22 |
NDC 57883-401-05 [57883040105]
Keralac CREAM
| Marketing Category | unapproved drug other |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2011-07-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| UREA | 470 mg/g |
OpenFDA Data
| SPL SET ID: | eccfae7f-4b53-4781-b198-f7c18366bfc9 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "Keralac" or generic name "Urea"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 57883-401 | Keralac | Keralac |
| 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 |
Trademark Results [Keralac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KERALAC 85918494 4557180 Live/Registered |
BKK Pharmaceuticals, LLC 2013-04-30 |
 KERALAC 78344472 3142922 Dead/Cancelled |
FOUGERA PHARMACEUTICALS INC. 2003-12-22 |
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