Prescription drug · NDA
Silver Sulfadiazine NDC 76420-208
Silver sulfadiazine 10 g/1000g · Cream · Topical · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-208-25 | 76420020825 | 25 g in 1 TUBE (76420-208-25)Marketed from Mar 9, 2022 | |
| 76420-208-50 | 76420020850 | 50 g in 1 TUBE (76420-208-50)Marketed from Mar 9, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Silver Sulfadiazine
- Generic name (nonproprietary)
- silver sulfadiazine
- Active ingredients
- Silver sulfadiazine — 10 g/1000g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018578
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonamides (Chemical structure)
- Identifiers
- Product ID 76420-208_d9c1d5d3-ee58-76e3-e053-2995a90ae559SPL ID d9c1d5d3-ee58-76e3-e053-2995a90ae559SPL set ID bee162c3-2627-4f28-9715-11a351d497ebRxCUI 106351UNII W46JY43EJR
- Pharmacologic class
- Sulfonamide Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476420020825followed by a unit qualifier and the quantityPackage 76420-0208-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018578
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| SSD Creamsilver sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | Dr Reddys Laboratories Inc | 43598-210 |
| SSD Creamsilver sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8074 |
| SSD Creamsilver sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | NuCare Pharmaceuticals, Inc. | 68071-3867 |
| Silver Sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | DIRECT RX | 61919-237 |
| Ssdsilver sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | A-S Medication Solutions | 50090-7447 |
| Silver Sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-2473 |
| SSD Creamsilver sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | St. Mary's Medical Park Pharmacy | 60760-962 |