Prescription drug · ANDA
Prednisolone Sodium Phosphate NDC 42799-812
Prednisolone sodium phosphate 10 mg/5mL · Solution · Oral · Edenbridge Pharmaceuticals LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42799-812-01 | 4279908120142799081201 | 237 mL in 1 BOTTLE, PLASTIC (42799-812-01)Marketed from Nov 11, 2011 |
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 — 10 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
- 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 42799-812_462f70d9-438c-e6b2-e063-6394a90a1bbbSPL ID 462f70d9-438c-e6b2-e063-6394a90a1bbbSPL set ID 1793e218-7b49-497d-879f-1020de6e6d68RxCUI 249066, 283077, 702306, 794979UNII IV021NXA9JUPC 0342799813011, 0342799816012, 0342799815015, 0342799812014
- 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
N442799081201followed by a unit qualifier and the quantityPackage 42799-0812-01. 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.
About NDC 42799-812
- What is NDC 42799-812?
- 42799-812 is the product NDC for Prednisolone Sodium Phosphate, Prednisolone sodium phosphate 10 mg/5mL solution, listed with the FDA by Edenbridge 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?
- Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. 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 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 | ATLANTIC BIOLOGICALS CORP. | 17856-0815 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Atlantic Biologicals Corp | 17856-8815 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 20 mg/5mL | SolutionOral | Edenbridge Pharmaceuticals LLC. | 42799-813 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Edenbridge Pharmaceuticals LLC. | 42799-815 |
| 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 | Redpharm Drug | 67296-2134 |
| Prednisolone Sodium Phosphate | Prednisolone sodium phosphate 15 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-4046 |