Sulfacetamide Sodium and Prednisolone Sodium Phosphate
- Product NDC
- 53002-8690
- 11-digit product format
- 530028690
- Labeler code
- 53002
- Product ID
- 53002-8690_cb1c01d1-f185-4005-9390-6797b9d42e31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfacetamide Sodium and Prednisolone Sodium Phosphate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA074449
- Marketing category
- ANDA
- Marketing start
- 1995-12-29
- Marketing end
- 0000-00-00
- Substance
- SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE
- Active strength
- 100 mg/mL; mg/mL
- Pharmacologic classes
- Sulfonamide Antibacterial [EPC],Sulfonamides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-8690-1 | Sulfacetamide Sodium and Prednisolone Sodium Phosphate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 5 |
| 53002-8690-2 | Sulfacetamide Sodium and Prednisolone Sodium Phosphate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-8690 | SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20230609_f3e88cc8-90df-4119-8c81-4c92f3cef5aa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-8690-1 | 53002869001 | 5 mL in 1 BOTTLE, DROPPER (53002-8690-1) | 5 ml | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-8690-2 | 53002869002 | 10 mL in 1 BOTTLE, DROPPER (53002-8690-2) | 10 ml | 2018-10-01 | 0000-00-00 | No | No | Current |