sulfacetamide sodium and prednisolone sodium phosphate

Generic: sulfacetamide sodium and prednisolone sodium phosphate

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfacetamide sodium and prednisolone sodium phosphate
Generic Name sulfacetamide sodium and prednisolone sodium phosphate
Labeler nucare pharmaceuticals,inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

prednisolone sodium phosphate 2.3 mg/mL, sulfacetamide sodium 100 mg/mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-1650
Product ID 68071-1650_1d4de4f7-e86f-d269-e063-6294a90ab688
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074449
Listing Expiration 2026-12-31
Marketing Start 1995-12-29

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc] sulfonamide antibacterial [epc] sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680711650
Hyphenated Format 68071-1650

Supplemental Identifiers

RxCUI
1012021
UPC
0368071165050
UNII
IV021NXA9J 4NRT660KJQ

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sulfacetamide sodium and prednisolone sodium phosphate (source: ndc)
Generic Name sulfacetamide sodium and prednisolone sodium phosphate (source: ndc)
Application Number ANDA074449 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.3 mg/mL
  • 100 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOX (68071-1650-5)
source: ndc

Packages (1)

68071-1650-5 5 mL in 1 BOX (68071-1650-5)

Ingredients (2)

prednisolone sodium phosphate (2.3 mg/mL) sulfacetamide sodium (100 mg/mL)

Linked Drug Pages (1)

Sulfacetamide Sodium and Prednisolone Sodium Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1d4de4f7-e86f-d269-e063-6294a90ab688", "openfda": {"upc": ["0368071165050"], "unii": ["IV021NXA9J", "4NRT660KJQ"], "rxcui": ["1012021"], "spl_set_id": ["835def0b-ed5a-61a0-e053-2a91aa0ae7ae"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOX (68071-1650-5)", "package_ndc": "68071-1650-5", "marketing_start_date": "20190305"}], "brand_name": "Sulfacetamide Sodium and Prednisolone Sodium Phosphate", "product_id": "68071-1650_1d4de4f7-e86f-d269-e063-6294a90ab688", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Sulfonamide Antibacterial [EPC]", "Sulfonamides [CS]"], "product_ndc": "68071-1650", "generic_name": "Sulfacetamide Sodium and Prednisolone Sodium Phosphate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfacetamide Sodium and Prednisolone Sodium Phosphate", "active_ingredients": [{"name": "PREDNISOLONE SODIUM PHOSPHATE", "strength": "2.3 mg/mL"}, {"name": "SULFACETAMIDE SODIUM", "strength": "100 mg/mL"}], "application_number": "ANDA074449", "marketing_category": "ANDA", "marketing_start_date": "19951229", "listing_expiration_date": "20261231"}