Prescription drug · ANDA
Prednisolone NDC 50090-7115
Prednisolone 15 mg/5mL · Solution · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7115-0 | 50090711500 | 2 BOTTLE, DISPENSING in 1 BOTTLE (50090-7115-0) / 120 mL in 1 BOTTLE, DISPENSINGMarketed from Mar 12, 2024 | |
| 50090-7115-1 | 50090711501 | 4 BOTTLE, DISPENSING in 1 BOTTLE (50090-7115-1) / 60 mL in 1 BOTTLE, DISPENSINGMarketed from Mar 12, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Active ingredients
- Prednisolone — 15 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040571
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 50090-7115_9a49f696-0cdf-45d7-adc4-f1cb1fbb690bSPL ID 9a49f696-0cdf-45d7-adc4-f1cb1fbb690bSPL set ID 35f0b197-c3ae-445a-8da7-9ffcd4472e05RxCUI 283077UNII 9PHQ9Y1OLM
- 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
N450090711500followed by a unit qualifier and the quantityPackage 50090-7115-00. 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 (sel…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040571
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 | Prednisolone 15 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0885 |