Prescription drug · ANDA
Sulfacetamide Sodium NDC 76420-090
Sulfacetamide sodium 100 mg/mL · Solution/ drops · Ophthalmic · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-090-15 | 7642000901576420009015 | 15 mL in 1 BOTTLE, DROPPER (76420-090-15)Marketed from Oct 24, 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/ drops
- Route
- Ophthalmic
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040066
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonamides (Chemical structure)
- Identifiers
- Product ID 76420-090_b26a1d2a-bf50-4787-e053-2a95a90a951bSPL ID b26a1d2a-bf50-4787-e053-2a95a90a951bSPL set ID 129d5dd9-32a4-4398-862d-820cd4468448RxCUI 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
N476420009015followed by a unit qualifier and the quantityPackage 76420-0090-15. 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.
About NDC 76420-090
- What is NDC 76420-090?
- 76420-090 is the product NDC for Sulfacetamide Sodium, Sulfacetamide sodium 100 mg/mL solution/ drops, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sulfacetamide Sodium.
- What is the active ingredient?
- Sulfacetamide sodium.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. 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?
- 11 other product NDCs are listed under this name. See all Sulfacetamide Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sulfacetamide Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | LiquidTopical | Cintex Services, LLC | 24470-937 | 24470-0937-06 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | GelTopical | Cintex Services, LLC | 24470-935 | 24470-0935-12 |
| Sulfacetamide Sodium | Sulfacetamide sodium 98 mg/mL | ShampooTopical | KMM Pharmaceuticals, LLC | 52187-553 | 52187-0553-08 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | LotionTopical | Padagis Israel Pharmaceuticals Ltd | 45802-896 | 45802-0896-26 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals, Inc | 68788-9871 | 68788-9871-01 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | LiquidTopical | BioComp Pharma, Inc. | 44523-568 | 44523-0568-12 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | SolutionOphthalmic | Asclemed USA, Inc. | 76420-076 | 76420-0076-15 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-670 | 24208-0670-04 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-0246 | 50090-0246-00 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-5123 | 68071-5123-05 |
Other NDCs under ANDA 040066
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 |
|---|---|---|---|---|
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-670 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-0246 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-5123 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals, Inc | 68788-9871 |
| Sulfacetamide Sodium | Sulfacetamide sodium 100 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 71205-689 |