Prescription drug · UNAPPROVED DRUG OTHER
sulfacetamide sodium and sulfur Sodium Sulfacetamide - Sulfur (Sulfacetamide sodium and sulfur) NDC 28595-501
Sulfacetamide sodium 90 mg/mL; Sulfur 42.5 mg/mL · Suspension · Topical · Allegis Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 28595-501-08 | 2859505010828595050108 | 237 mL in 1 BOTTLE (28595-501-08)Marketed from Jun 18, 2024 |
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)
- sulfacetamide sodium and sulfur Sodium Sulfacetamide - SulfurSuffix: Sodium Sulfacetamide - Sulfur
- Generic name (nonproprietary)
- sulfacetamide sodium and sulfur
- Active ingredients
- Sulfacetamide sodium — 90 mg/mLSulfur — 42.5 mg/mL
- Dosage form
- Suspension
- Route
- Topical
- Labeler
- Allegis Pharmaceuticals, LLCNDC labeler code 28595
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonamides (Chemical structure)
- Identifiers
- Product ID 28595-501_4a912755-c660-18d3-e063-6294a90a1a38SPL ID 4a912755-c660-18d3-e063-6294a90a1a38SPL set ID 1aa1025f-c568-34d3-e063-6394a90a37b8RxCUI 2531383UNII 4NRT660KJQ, 70FD1KFU70
- 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
N428595050108followed by a unit qualifier and the quantityPackage 28595-0501-08. 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 Sodium Sulfacetamide 9% - Sulfur 4.25% Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Excerpt only. Read the full label for complete information.
About NDC 28595-501
- What is NDC 28595-501?
- 28595-501 is the product NDC for sulfacetamide sodium and sulfur Sodium Sulfacetamide - Sulfur, Sulfacetamide sodium 90 mg/mL; Sulfur 42.5 mg/mL suspension, listed with the FDA by Allegis Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- sulfacetamide sodium and sulfur Sodium Sulfacetamide - Sulfur (Sulfacetamide sodium and sulfur).
- What is the active ingredient?
- Sulfacetamide sodium, Sulfur.
- Who is the labeler?
- Allegis Pharmaceuticals, LLC, NDC labeler code 28595. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for sulfacetamide sodium and sulfur Sodium Sulfacetamide - Sulfur?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.