Prescription drug · NDA
Silvadene (Silver sulfadiazine) NDC 50090-0230
Silver sulfadiazine 10 mg/g · Cream · Topical · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0230-0 | 5009002300050090023000 | 1 TUBE in 1 CARTON (50090-0230-0) / 20 g in 1 TUBEMarketed from Jun 29, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-0230_c49d23c9-9da7-46d4-872a-607b71a2c700SPL ID c49d23c9-9da7-46d4-872a-607b71a2c700SPL set ID 54b77a36-205b-4044-9ecb-c5130f0934b5RxCUI 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
N450090023000followed by a unit qualifier and the quantityPackage 50090-0230-00. 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 50090-0230
- What is NDC 50090-0230?
- 50090-0230 is the product NDC for Silvadene (silver sulfadiazine), Silver sulfadiazine 10 mg/g cream, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 | Pfizer Laboratories Div Pfizer Inc | 61570-131 | 61570-0131-2061570-0131-2561570-0131-40+4 more |
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 | Pfizer Laboratories Div Pfizer Inc | 61570-131 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | Mylan Pharmaceuticals Inc. | 59762-0131 |