Prescription drug · NDA
Silver Sulfadiazine NDC 80425-0221
Silver sulfadiazine 10 mg/g · Cream · Topical · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0221-1 | 8042502210180425022101 | 50 g in 1 TUBE (80425-0221-1)Marketed from Jan 12, 2023 |
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)
- Silver Sulfadiazine
- Generic name (nonproprietary)
- silver sulfadiazine
- Active ingredients
- Silver sulfadiazine — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018810
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonamides (Chemical structure)
- Identifiers
- Product ID 80425-0221_2a9b1617-60ce-f8ce-e063-6294a90ab02cSPL ID 2a9b1617-60ce-f8ce-e063-6294a90ab02cSPL set ID f1a0f489-0d9e-66c4-e053-2a95a90a063dRxCUI 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
N480425022101followed by a unit qualifier and the quantityPackage 80425-0221-01. 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, USP 1% 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 80425-0221
- What is NDC 80425-0221?
- 80425-0221 is the product NDC for Silver Sulfadiazine, Silver sulfadiazine 10 mg/g cream, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Silver Sulfadiazine.
- What is the active ingredient?
- Silver sulfadiazine.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Silver Sulfadiazine?
- 11 other product NDCs are listed under this name. See all Silver Sulfadiazine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Silver Sulfadiazine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | Mylan Pharmaceuticals Inc. | 59762-0131 | 59762-0131-0059762-0131-0259762-0131-04+3 more |
| Silver Sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | DIRECT RX | 61919-237 | 61919-0237-25 |
| Silver Sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-2473 | 68071-2473-05 |
| Silver Sulfadiazine | Silver sulfadiazine 10 g/1000g | CreamTopical | Asclemed USA, Inc. | 76420-208 | 76420-0208-2576420-0208-50 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-0607 | 50090-0607-00 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-0717 | 50090-0717-00 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-0763 | 50090-0763-00 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-2152 | 50090-2152-00 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | Proficient Rx LP | 63187-023 | 63187-0023-2563187-0023-51 |
| Silver sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | Ascend Laboratories, LLC | 67877-124 | 67877-0124-0567877-0124-1067877-0124-20+4 more |
Other NDCs under NDA 018810
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 |
|---|---|---|---|---|
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-0607 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-0717 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-0763 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-2152 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | Proficient Rx LP | 63187-023 |
| Silver sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | Ascend Laboratories, LLC | 67877-124 |
| Silver Sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | Asclemed USA, Inc. | 87063-078 |
| Thermazene Silver Sulfadiazinesilver sulfadiazine | Silver sulfadiazine 10 mg/g | CreamTopical | Preferred Pharmaceuticals, Inc. | 68788-0600 |