Prescription drug · ANDA
Sulfacetamide Sodium and Prednisolone Sodium Phosphate NDC 68071-1650
Sulfacetamide sodium 100 mg/mL; Prednisolone sodium phosphate 2.3 mg/mL · Solution/ drops · Ophthalmic · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-1650-5 | 6807116500568071165005 | 5 mL in 1 BOX (68071-1650-5)Marketed from Mar 5, 2019 |
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)
- Sulfacetamide Sodium and Prednisolone Sodium Phosphate
- Generic name (nonproprietary)
- sulfacetamide sodium and prednisolone sodium phosphate
- Active ingredients
- Sulfacetamide sodium — 100 mg/mLPrednisolone sodium phosphate — 2.3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074449
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 68071-1650_1d4de4f7-e86f-d269-e063-6294a90ab688SPL ID 1d4de4f7-e86f-d269-e063-6294a90ab688SPL set ID 835def0b-ed5a-61a0-e053-2a91aa0ae7aeRxCUI 1012021UNII 4NRT660KJQ, IV021NXA9JUPC 0368071165050
- Pharmacologic class
- Corticosteroid; 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
N468071165005followed by a unit qualifier and the quantityPackage 68071-1650-05. 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 and Prednisolone Sodium Phosphate Ophthalmic Solution is indicated for corticosteroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or t…
Excerpt only. Read the full label for complete information.
About NDC 68071-1650
- What is NDC 68071-1650?
- 68071-1650 is the product NDC for Sulfacetamide Sodium and Prednisolone Sodium Phosphate, Sulfacetamide sodium 100 mg/mL; Prednisolone sodium phosphate 2.3 mg/mL solution/ drops, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sulfacetamide Sodium and Prednisolone Sodium Phosphate.
- What is the active ingredient?
- Sulfacetamide sodium, Prednisolone sodium phosphate.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 Prednisolone Sodium Phosphate?
- 1 other product NDC are listed under this name. See all Sulfacetamide Sodium and Prednisolone Sodium Phosphate 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 and Prednisolone Sodium Phosphate 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 and Prednisolone Sodium Phosphate | Sulfacetamide sodium 100 mg/mL; Prednisolone sodium phosphate 2.3 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incoporated | 24208-317 | 24208-0317-0524208-0317-10 |
Other NDCs under ANDA 074449
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 and Prednisolone Sodium Phosphate | Sulfacetamide sodium 100 mg/mL; Prednisolone sodium phosphate 2.3 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incoporated | 24208-317 |