NDC 53097-101
Thermazene
Silver Sulfadiazine
Thermazene is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by The Pharma Network Llc. The primary component is Silver Sulfadiazine.
| Product ID | 53097-101_331af50e-8cf9-46f3-a8db-e76632739c92 |
| NDC | 53097-101 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Thermazene |
| Generic Name | Silver Sulfadiazine |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2013-07-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA018810 |
| Labeler Name | The Pharma Network LLC |
| Substance Name | SILVER SULFADIAZINE |
| Active Ingredient Strength | 10 mg/g |
| Pharm Classes | Sulfonamide Antibacterial [EPC],Sulfonamides [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC 53097-101-85
85 g in 1 TUBE (53097-101-85)
| Marketing Start Date | 2013-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 53097-101-40 [53097010140]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2013-07-01 |
| Inactivation Date | 2020-01-31 |
NDC 53097-101-50 [53097010150]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2013-07-01 |
| Inactivation Date | 2020-01-31 |
NDC 53097-101-10 [53097010110]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2013-07-01 |
| Inactivation Date | 2020-01-31 |
NDC 53097-101-85 [53097010185]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2013-07-01 |
| Inactivation Date | 2020-01-31 |
NDC 53097-101-25 [53097010125]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-07-01 |
| Inactivation Date | 2020-01-31 |
NDC 53097-101-20 [53097010120]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2013-07-01 |
| Inactivation Date | 2020-01-31 |
NDC 53097-101-05 [53097010105]
Thermazene CREAM
| Marketing Category | NDA |
| Application Number | NDA018810 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2013-07-01 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SILVER SULFADIAZINE | 10 mg/g |
OpenFDA Data
| SPL SET ID: | b63d13c5-90e0-4de8-a075-795bfe8b91a1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.