Prescription drug · ANDA
Prednisolone Sodium Phosphate NDC 68788-7708
Prednisolone sodium phosphate 15 mg/5mL · Solution · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7708-2 | 68788770802 | 237 mL in 1 BOTTLE (68788-7708-2)Marketed from Jun 1, 2020 |
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 Sodium Phosphate
- Generic name (nonproprietary)
- prednisolone sodium phosphate
- Active ingredients
- Prednisolone sodium phosphate — 15 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076913
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68788-7708_947eeaee-1645-4a12-a02f-f33fc4ddf121SPL ID 947eeaee-1645-4a12-a02f-f33fc4ddf121SPL set ID 93b372f7-b811-4c15-85c4-c6dbac342cb4RxCUI 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
N468788770802followed by a unit qualifier and the quantityPackage 68788-7708-02. 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 sodium phosphate oral solution is 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; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus er…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076913
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 | Proficient Rx LP | 63187-215 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | REMEDYREPACK INC. | 70518-4524 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0759 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4759 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-1582 |