NDC 10631-102
Ultravate
Halobetasol Propionate
Ultravate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Ranbaxy Laboratories Inc.. The primary component is Halobetasol Propionate.
| Product ID | 10631-102_cd9a3fc1-f9e4-4ab7-9c75-50ab9c65e270 |
| NDC | 10631-102 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ultravate |
| Generic Name | Halobetasol Propionate |
| Dosage Form | Ointment |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2009-02-20 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019968 |
| Labeler Name | Ranbaxy Laboratories Inc. |
| Substance Name | HALOBETASOL PROPIONATE |
| Active Ingredient Strength | 1 mg/g |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC 10631-102-50
1 TUBE in 1 CARTON (10631-102-50) > 50 g in 1 TUBE
| Marketing Start Date | 2009-02-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 10631-102-04 [10631010204]
Ultravate OINTMENT
| Marketing Category | NDA |
| Application Number | NDA019968 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-02-20 |
| Marketing End Date | 2017-06-30 |
NDC 10631-102-50 [10631010250]
Ultravate OINTMENT
| Marketing Category | NDA |
| Application Number | NDA019968 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2009-02-20 |
| Marketing End Date | 2020-01-18 |
NDC 10631-102-15 [10631010215]
Ultravate OINTMENT
| Marketing Category | NDA |
| Application Number | NDA019968 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2009-02-20 |
| Marketing End Date | 2012-06-08 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HALOBETASOL PROPIONATE | .5 mg/g |
OpenFDA Data
| SPL SET ID: | 031f1120-7da1-4ea6-a0be-d368018e2c1f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
NDC Crossover Matching brand name "Ultravate" or generic name "Halobetasol Propionate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10631-102 | Ultravate | halobetasol propionate |
| 10631-103 | Ultravate | halobetasol propionate |
| 10631-122 | Ultravate | halobetasol propionate |
| 0187-0002 | Bryhali | halobetasol propionate |
| 0168-0355 | Halobetasol Propionate | halobetasol propionate |
| 0168-0356 | Halobetasol Propionate | halobetasol propionate |
| 0713-0339 | Halobetasol Propionate | Halobetasol Propionate |
| 0713-0639 | Halobetasol Propionate | Halobetasol Propionate |
| 0713-0640 | Halobetasol Propionate | Halobetasol Propionate |
| 0713-0758 | Halobetasol Propionate | Halobetasol Propionate |
| 42254-250 | Halobetasol Propionate | Halobetasol Propionate |
| 45802-129 | Halobetasol Propionate | Halobetasol Propionate |
| 45802-131 | Halobetasol Propionate | Halobetasol Propionate |
| 51672-1321 | Halobetasol Propionate | Halobetasol Propionate |
| 51672-1322 | Halobetasol Propionate | Halobetasol Propionate |
| 51862-606 | Halobetasol propionate | Halobetasol propionate |
| 52565-073 | Halobetasol Propionate | halobetasol propionate |
| 52959-961 | Halobetasol Propionate | Halobetasol Propionate |
| 55337-606 | Halobetasol propionate | Halobetasol propionate |
| 63629-8664 | Halobetasol Propionate | Halobetasol Propionate |
| 51862-604 | LEXETTE | Halobetasol propionate |
| 10631-119 | Ultravate X | Halobetasol Propionate |
| 10631-121 | Ultravate X | Halobetasol Propionate |
Trademark Results [Ultravate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRAVATE 74024962 1647847 Live/Registered |
Westwood Pharmaceuticals Inc. 1990-02-05 |
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