Prescription drug · ANDA
PredniSONE Intensol NDC 0054-3721
Prednisone 5 mg/mL · Solution, Concentrate · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-3721-44 | 00054372144 | 30 mL in 1 BOTTLE, GLASS (0054-3721-44)Marketed from Feb 20, 1985 |
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)
- PredniSONE Intensol
- Generic name (nonproprietary)
- prednisone intensol
- Active ingredients
- Prednisone — 5 mg/mL
- Dosage form
- Solution, Concentrate
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088810
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0054-3721_523ad364-8d95-4679-9290-446d61f36eb5SPL ID 523ad364-8d95-4679-9290-446d61f36eb5SPL set ID 3115aef0-fd50-4ec8-a064-3effb695f3f2RxCUI 198144, 198145, 198146, 198148, 205301, 312615, 312617, 315187UNII VB0R961HZTUPC 0300543722507
- 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
N400054372144followed by a unit qualifier and the quantityPackage 00054-3721-44. 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 Prednisone tablets and solutions are 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 Hypercalcemia associated with cancer Nonsuppurative thyroiditis 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 rheumatoid arthritis (selected ca…
Excerpt only. Read the full label for complete information.