Prescription drug · NDA
Silvadene (Silver sulfadiazine) NDC 61570-131
Silver sulfadiazine 10 mg/g · Cream · Topical · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61570-131-20 | 6157001312061570013120 | 1 TUBE in 1 CARTON (61570-131-20) / 20 g in 1 TUBEMarketed from Nov 26, 1973 | |
| 61570-131-25 | 6157001312561570013125 | 1 TUBE in 1 CARTON (61570-131-25) / 25 g in 1 TUBEMarketed from May 26, 2015 | |
| 61570-131-40 | 6157001314061570013140 | 400 g in 1 JAR (61570-131-40)Marketed from Nov 26, 1973 | |
| 61570-131-50 | 6157001315061570013150 | 50 g in 1 JAR (61570-131-50)Marketed from Nov 26, 1973 | |
| 61570-131-55 | 6157001315561570013155 | 1 TUBE in 1 CARTON (61570-131-55) / 50 g in 1 TUBEMarketed from May 26, 2015 | |
| 61570-131-85 | 6157001318561570013185 | 1 TUBE in 1 CARTON (61570-131-85) / 85 g in 1 TUBEMarketed from Nov 26, 1973 | |
| 61570-131-98 | 6157001319861570013198 | 1000 g in 1 JAR (61570-131-98)Marketed from Nov 26, 1973 |
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)
- Silvadene
- Generic name (nonproprietary)
- silver sulfadiazine
- Active ingredients
- Silver sulfadiazine — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 61570
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017381
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonamides (Chemical structure)
- Identifiers
- Product ID 61570-131_2d9a5dc8-0dfd-42b8-a641-b4b82a113fabSPL ID 2d9a5dc8-0dfd-42b8-a641-b4b82a113fabSPL set ID c437213a-1cd4-445e-a39f-bbcacb9f746fRxCUI 106351, 208186UNII 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
N461570013120followed by a unit qualifier and the quantityPackage 61570-0131-20. 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 SILVADENE Cream 1% (silver sulfadiazine) 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.
About NDC 61570-131
- What is NDC 61570-131?
- 61570-131 is the product NDC for Silvadene (silver sulfadiazine), Silver sulfadiazine 10 mg/g cream, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Silvadene (Silver sulfadiazine).
- What is the active ingredient?
- Silver sulfadiazine.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 61570. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Silvadene?
- 1 other product NDC are listed under this name. See all Silvadene NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Silvadene products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Silvadenesilver sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-0230 | 50090-0230-00 |
Other NDCs under NDA 017381
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 |
|---|---|---|---|---|
| Silvadenesilver sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-0230 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | Mylan Pharmaceuticals Inc. | 59762-0131 |