Prescription drug · ANDA
PrednisoLONE NDC 0527-5406
Prednisolone 15 mg/5mL · Syrup · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-5406-68 | 00527540668 | 240 mL in 1 BOTTLE (0527-5406-68)Marketed from Sep 21, 2007 | |
| 0527-5406-70 | 00527540670 | 480 mL in 1 BOTTLE (0527-5406-70)Marketed from Sep 21, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Generic name (nonproprietary)
- prednisolone
- Active ingredients
- Prednisolone — 15 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040775
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0527-5406_5122ba73-5783-49f0-9b9c-a03d59d8899cSPL ID 5122ba73-5783-49f0-9b9c-a03d59d8899cSPL set ID 86652e2d-664a-4388-a611-c2a9aa4a4bc8RxCUI 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
N400527540668followed by a unit qualifier and the quantityPackage 00527-5406-68. 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 Syrup (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 rhe…
Excerpt only. Read the full label for complete information.