Prescription drug · ANDA
prednisoLONE sodium phosphate NDC 81033-021
Prednisolone sodium phosphate 15 mg/5mL · Solution · Oral · Kesin Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81033-021-54 | 81033002154 | 50 CUP, UNIT-DOSE in 1 CARTON (81033-021-54) / 5 mL in 1 CUP, UNIT-DOSE (81033-021-05)Marketed from Mar 27, 2026 |
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)
- prednisoLONE sodium phosphate
- Generic name (nonproprietary)
- prednisolone sodium phosphate
- Active ingredients
- Prednisolone sodium phosphate — 15 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Kesin Pharma
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203559
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 81033-021_4c0dce2f-a772-65cb-e063-6294a90a158eSPL ID 4c0dce2f-a772-65cb-e063-6294a90a158eSPL set ID 4c0dcbfd-2848-9bd0-e063-6394a90af5a7RxCUI 283077UNII IV021NXA9J
- Pharmacologic class
- Corticosteroid
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N481033002154followed by a unit qualifier and the quantityPackage 81033-0021-54. 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 & USAGE Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate (25 mg Prednisolone per 5 mL) are indicated in the following conditions: 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases Pemphigus; bul…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203559
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 |
|---|---|---|---|---|
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Redpharm Drug | 67296-2134 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-4046 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Edenbridge Pharmaceuticals LLC. | 42799-815 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 10 mg/5mL | SolutionOral | Edenbridge Pharmaceuticals LLC. | 42799-812 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 20 mg/5mL | SolutionOral | Edenbridge Pharmaceuticals LLC. | 42799-813 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 25 mg/5mL | SolutionOral | Edenbridge Pharmaceuticals LLC. | 42799-816 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Atlantic Biologicals Corp | 17856-8815 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0815 |