NDC 53002-8690

Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Sulfacetamide Sodium And Prednisolone Sodium Phosphate

Sulfacetamide Sodium and Prednisolone Sodium Phosphate is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Sulfacetamide Sodium; Prednisolone Sodium Phosphate.

• Product ID: 53002-8690_1287ff6a-ff1d-417d-941c-215c81f903fc
• NDC: 53002-8690
• Product Type: Human Prescription Drug
• Proprietary Name: Sulfacetamide Sodium and Prednisolone Sodium Phosphate
• Generic Name: Sulfacetamide Sodium And Prednisolone Sodium Phosphate
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1995-12-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074449
• Labeler Name: RPK Pharmaceuticals, Inc.
• Substance Name: SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE
• Active Ingredient Strength: 100 mg/mL; mg/mL
• Pharm Classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53002-8690-1

5 mL in 1 BOTTLE, DROPPER (53002-8690-1)

• Marketing Start Date: 2018-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53002-8690-1 [53002869001]

Sulfacetamide Sodium and Prednisolone Sodium Phosphate SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA074449
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-01
• Inactivation Date: 2020-01-31

NDC 53002-8690-2 [53002869002]

Sulfacetamide Sodium and Prednisolone Sodium Phosphate SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA074449
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SULFACETAMIDE SODIUM	100 mg/mL

OpenFDA Data

• SPL SET ID: f3e88cc8-90df-4119-8c81-4c92f3cef5aa
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• UNII:
  • IV021NXA9J
  • 4NRT660KJQ
• RxNorm Concept Unique ID - RxCUI:
  • 1012021

Pharmacological Class

• Sulfonamide Antibacterial [EPC]
• Sulfonamides [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Sulfacetamide Sodium and Prednisolone Sodium Phosphate" or generic name "Sulfacetamide Sodium And Prednisolone Sodium Phosphate"

NDC	Brand Name	Generic Name
21695-186	Sulfacetamide Sodium and Prednisolone Sodium Phosphate	sulfacetamide sodium and prednisolone sodium phosphate
24208-317	Sulfacetamide Sodium and Prednisolone Sodium Phosphate	Sulfacetamide Sodium and Prednisolone Sodium Phosphate
53002-8690	Sulfacetamide Sodium and Prednisolone Sodium Phosphate	Sulfacetamide Sodium and Prednisolone Sodium Phosphate
68071-1650	Sulfacetamide Sodium and Prednisolone Sodium Phosphate	Sulfacetamide Sodium and Prednisolone Sodium Phosphate
70518-2559	Sulfacetamide Sodium and Prednisolone Sodium Phosphate	Sulfacetamide Sodium and Prednisolone Sodium Phosphate