Prescription drug · NDA
Silver Sulfadiazine NDC 61919-237
Silver sulfadiazine 10 g/1000g · Cream · Topical · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-237-25 | 61919023725 | 25 g in 1 TUBE (61919-237-25)Marketed from Jan 1, 2015 |
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
- DIRECT RX
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018578
- Marketing start
- Marketing end
- Identifiers
- Product ID 61919-237_4d3a460b-1b9a-2906-e063-6294a90a3669SPL ID 4d3a460b-1b9a-2906-e063-6294a90a3669SPL set ID 7ef0cf79-e960-44a6-acac-797913b71c97RxCUI 106351UNII W46JY43EJR
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
N461919023725followed by a unit qualifier and the quantityPackage 61919-0237-25. 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 & USAGE SECTION 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 |
| Silver Sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | Asclemed USA, Inc. | 76420-208 |
| 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 |
| 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 |