Prescription drug · ANDA
Sulfacetamide Sodium NDC 76420-076
Sulfacetamide sodium 100 mg/mL · Solution · Ophthalmic · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-076-15 | 76420007615 | 15 mL in 1 BOTTLE, PLASTIC (76420-076-15)Marketed from Jan 16, 2020 |
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
- Generic name (nonproprietary)
- sulfacetamide sodium
- Active ingredients
- Sulfacetamide sodium — 100 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089560
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonamides (Chemical structure)
- Identifiers
- Product ID 76420-076_ead2d6e4-62f6-3b3c-e053-2a95a90a4ccdSPL ID ead2d6e4-62f6-3b3c-e053-2a95a90a4ccdSPL set ID c4c29e13-8303-4a9a-bb47-d7413eaf2f26RxCUI 1006120UNII 4NRT660KJQ
- 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476420007615followed by a unit qualifier and the quantityPackage 76420-0076-15. 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: Sulfacetamide Sodium Ophthalmic Solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa . A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
Excerpt only. Read the full label for complete information.