Thermazene
- Product NDC
- 68788-0600
- 11-digit product format
- 687880600
- Labeler code
- 68788
- Product ID
- 68788-0600_98948242-c0ca-49e7-beb5-fec0105fc40a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Silver Sulfadiazine
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- NDA018810
- Marketing category
- NDA
- Marketing start
- 2013-09-04
- Substance
- SILVER SULFADIAZINE
- Active strength
- 10 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Thermazene
- Brand name suffix
- Silver Sulfadiazine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SILVER SULFADIAZINE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W46JY43EJR |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-0600-2 | ThermazeneSilver Sulfadiazine | 25 g in 1 TUBE | CREAM | 25 | | 13 |
| 68788-0600-4 | ThermazeneSilver Sulfadiazine | 400 g in 1 JAR | CREAM | 400 | | 13 |
| 68788-0600-5 | ThermazeneSilver Sulfadiazine | 50 g in 1 JAR | CREAM | 50 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Silver Sulfadiazine | ACTIVE INGREDIENT | W46JY43EJR | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| SILVER CATION | ACTIVE MOIETY | 57N7B0K90A | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| Isopropyl Myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| Petrolatum | INACTIVE INGREDIENT | 4T6H12BN9U | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| Polyoxyl 40 Stearate | INACTIVE INGREDIENT | 13A4J4NH9I | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| Sorbitan Monooleate | INACTIVE INGREDIENT | 06XEA2VD56 | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| Stearyl Alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-0600 | THERMAZENE SILVER SULFADIAZINE (SILVER SULFADIAZINE) CREAM [PREFERRED PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240810_42c3ece4-0df0-4ed8-ac0f-a65fad19eed7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-0600-2 | 68788060002 | 25 g in 1 TUBE (68788-0600-2) | 25 g | 2015-11-16 | 0000-00-00 | No | No | Current |
| 68788-0600-4 | 68788060004 | 400 g in 1 JAR (68788-0600-4) | 400 g | 2016-10-04 | 0000-00-00 | No | No | Current |
| 68788-0600-5 | 68788060005 | 50 g in 1 JAR (68788-0600-5) | 50 g | 2013-09-04 | 0000-00-00 | No | No | Current |