Prescription drug · NDA
Prednisolone Sodium Phosphate NDC 13925-166
Prednisolone sodium phosphate 5 mg/5mL · Solution · Oral · Seton Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13925-166-04 | 1392501660413925016604 | 120 mL in 1 BOTTLE (13925-166-04)Marketed from Oct 18, 2013 |
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 — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Seton Pharmaceuticals, LLCNDC labeler code 13925
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019157
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 13925-166_da94c24a-0943-4544-8286-467d7c073c34SPL ID da94c24a-0943-4544-8286-467d7c073c34SPL set ID 833ba492-8823-43b4-9a91-8b28d94a740bRxCUI 312614UNII IV021NXA9JUPC 0313925166042
- 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
N413925016604followed by a unit qualifier and the quantityPackage 13925-0166-04. 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.
About NDC 13925-166
- What is NDC 13925-166?
- 13925-166 is the product NDC for Prednisolone Sodium Phosphate, Prednisolone sodium phosphate 5 mg/5mL solution, listed with the FDA by Seton Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prednisolone Sodium Phosphate.
- What is the active ingredient?
- Prednisolone sodium phosphate.
- Who is the labeler?
- Seton Pharmaceuticals, LLC, NDC labeler code 13925. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prednisolone Sodium Phosphate?
- 21 other product NDCs are listed under this name. See all Prednisolone Sodium Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prednisolone Sodium Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| PrednisoLONE Sodium Phosphate | Prednisolone sodium phosphate 5 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1100 | 00121-1100-04 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | REMEDYREPACK INC. | 70518-4524 | 70518-4524-0070518-4524-0270518-4524-04 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-4046 | 68788-4046-02 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4759 | 00121-4759-50 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0815 | 17856-0815-0117856-0815-0217856-0815-03+1 more |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Atlantic Biologicals Corp | 17856-8815 | 17856-8815-01 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Edenbridge Pharmaceuticals LLC. | 42799-815 | 42799-0815-01 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Redpharm Drug | 67296-2134 | 67296-2134-06 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 25 mg/5mL | SolutionOral | Edenbridge Pharmaceuticals LLC. | 42799-816 | 42799-0816-01 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Amneal Pharmaceuticals NY LLC | 69238-2122 | 69238-2122-09 |
Other NDCs under NDA 019157
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 5 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1100 |