NDC 8880-9505
Thermazene
Silver Sulfadiazine
Thermazene is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Covidien Inc.. The primary component is Silver Sulfadiazine.
| Product ID | 8880-9505_1394ceab-ed35-41fe-8ceb-bd2a83912d0f |
| NDC | 8880-9505 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Thermazene |
| Generic Name | Silver Sulfadiazine |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2012-08-20 |
| Marketing Category | NDA / NDA |
| Application Number | NDA018810 |
| Labeler Name | COVIDIEN INC. |
| Substance Name | SILVER SULFADIAZINE |
| Active Ingredient Strength | 10 mg/g |
| Pharm Classes | Sulfonamide Antibacterial [EPC],Sulfonamides [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 8880-9505-02
24 TUBE in 1 CASE (8880-9505-02) > 20 g in 1 TUBE
| Marketing Start Date | 2012-08-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 8880-9505-10 [08880950510]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-20 |
| Inactivation Date | 2019-11-13 |
NDC 8880-9505-40 [08880950540]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-20 |
| Inactivation Date | 2019-11-13 |
NDC 8880-9505-05 [08880950505]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-20 |
| Inactivation Date | 2019-11-13 |
NDC 8880-9505-50 [08880950550]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-20 |
| Inactivation Date | 2019-11-13 |
NDC 8880-9505-02 [08880950502]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-20 |
| Inactivation Date | 2019-11-13 |
NDC 8880-9505-85 [08880950585]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-20 |
| Inactivation Date | 2019-11-13 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SILVER SULFADIAZINE | 10 mg/g |
OpenFDA Data
| SPL SET ID: | b3767ee9-038e-43ff-88bf-2a4577ac608a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Sulfonamide Antibacterial [EPC]
- Sulfonamides [CS]
NDC Crossover Matching brand name "Thermazene" or generic name "Silver Sulfadiazine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 21695-182 | Thermazene | Silver Sulfadiazine |
| 53097-101 | Thermazene | Silver Sulfadiazine |
| 68788-9818 | Thermazene | Thermazene |
| 8880-9505 | Thermazene | Thermazene |
| 49999-143 | SILVADENE | silver sulfadiazine |
| 50090-0230 | SILVADENE | silver sulfadiazine |
| 61570-131 | SILVADENE | silver sulfadiazine |
| 0591-0810 | Silver Sulfadiazene | Silver Sulfadiazine |
| 42254-118 | Silver Sulfadiazene | Silver Sulfadiazine |
| 50436-3098 | Silver Sulfadiazene | Silver Sulfadiazine |
| 50436-3099 | Silver Sulfadiazene | Silver Sulfadiazine |
| 0440-0124 | Silver Sulfadiazine | Silver Sulfadiazine |
| 33261-589 | Silver Sulfadiazine | Silver Sulfadiazine |
| 45865-642 | Silver Sulfadiazine | Silver Sulfadiazine |
| 49999-185 | Silver Sulfadiazine | Silver Sulfadiazine |
| 50090-0607 | Silver Sulfadiazine | Silver Sulfadiazine |
| 50090-0717 | Silver Sulfadiazine | Silver Sulfadiazine |
| 50090-0763 | Silver Sulfadiazine | Silver Sulfadiazine |
| 50090-2152 | Silver Sulfadiazine | Silver Sulfadiazine |
| 50436-1240 | Silver Sulfadiazine | Silver Sulfadiazine |
| 52959-635 | Silver Sulfadiazine | Silver Sulfadiazine |
| 53002-9090 | Silver Sulfadiazine | Silver Sulfadiazine |
| 55700-068 | Silver Sulfadiazine | Silver Sulfadiazine |
| 59762-0131 | SILVER SULFADIAZINE | silver sulfadiazine |
| 61919-237 | Silver Sulfadiazine | Silver Sulfadiazine |
| 63187-023 | Silver Sulfadiazine | Silver Sulfadiazine |
| 63629-8768 | Silver Sulfadiazine | Silver Sulfadiazine |
| 43598-210 | SSD Cream | Silver Sulfadiazine |
| 50090-2288 | SSD Cream | Silver Sulfadiazine |
| 55700-640 | SSD Cream | Silver Sulfadiazine |
Trademark Results [Thermazene]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERMAZENE 97030487 not registered Live/Pending |
Ascend Laboratories, LLC 2021-09-16 |
 THERMAZENE 73681073 1485005 Live/Registered |
SHERWOOD MEDICAL COMPANY 1987-08-28 |
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