Prescription drug · ANDA
Prednisolone Sodium Phosphate Oral Solution (Prednisolone sodium phosphate) NDC 44523-182
Prednisolone sodium phosphate 25 mg/5mL · Solution · Oral · BioComp Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44523-182-08 | 4452301820844523018208 | 237 mL in 1 BOTTLE (44523-182-08)Marketed from Oct 28, 2019 |
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 Oral Solution
- Generic name (nonproprietary)
- prednisolone sodium phosphate
- Active ingredients
- Prednisolone sodium phosphate — 25 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- BioComp Pharma, Inc.NDC labeler code 44523
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091396
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 44523-182_450e8d3f-b6f6-5251-e063-6394a90aa439SPL ID 450e8d3f-b6f6-5251-e063-6394a90aa439SPL set ID 95208441-1700-5d3f-e053-2a95a90a7da2RxCUI 249066UNII IV021NXA9JUPC 0344523182080
- 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
N444523018208followed by a unit qualifier and the quantityPackage 44523-0182-08. 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 sodium phosphate oral solution (25 mg prednisolone per 5 mL) 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 sy…
Excerpt only. Read the full label for complete information.
About NDC 44523-182
- What is NDC 44523-182?
- 44523-182 is the product NDC for Prednisolone Sodium Phosphate Oral Solution, Prednisolone sodium phosphate 25 mg/5mL solution, listed with the FDA by BioComp Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prednisolone Sodium Phosphate Oral Solution (Prednisolone Sodium Phosphate).
- What is the active ingredient?
- Prednisolone sodium phosphate.
- Who is the labeler?
- BioComp Pharma, Inc., NDC labeler code 44523. 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 Oral Solution?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.