Prescription drug · ANDA
Prednisolone (prednisolone oral) NDC 52817-860
Prednisolone 15 mg/5mL · Solution · Oral · TRUPHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-860-08 | 52817086008 | 240 mL in 1 BOTTLE (52817-860-08)Marketed from Aug 4, 2026 | |
| 52817-860-16 | 52817086016 | 480 mL in 1 BOTTLE (52817-860-16)Marketed from Aug 4, 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
- Generic name (nonproprietary)
- prednisolone oral
- Active ingredients
- Prednisolone — 15 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- TRUPHARMA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219509
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 52817-860_5a84db26-98d0-fe51-e063-6294a90a63eeSPL ID 5a84db26-98d0-fe51-e063-6294a90a63eeSPL set ID 4f83514d-5342-4748-a0d3-b0306ca303c8RxCUI 283077UNII 9PHQ9Y1OLMUPC 0352817860163, 0352817860088
- 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
N452817086008followed by a unit qualifier and the quantityPackage 52817-0860-08. 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 Prednisolone Oral Solution, USP is indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (se…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219509
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 |
|---|---|---|---|---|
| Prednisoloneprednisolone oral | Prednisolone 15 mg/5mL | SolutionOral | Tulex Pharmaceuticals Inc | 70404-077 |