PredniSONE NDC 0054-3722

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-3722Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-3722Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0054-3722-50	00054372250	120 mL in 1 BOTTLE (0054-3722-50)Marketed from Dec 13, 1996
0054-3722-63	00054372263	500 mL in 1 BOTTLE (0054-3722-63)Marketed from Nov 8, 1984

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
Generic name (nonproprietary): prednisone
Active ingredients: Prednisone — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088703
Marketing start: Nov 8, 1984
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0054-3722_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

N400054372250 followed by a unit qualifier and the quantity

Package 00054-3722-50. 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 Apr 22, 2025.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 088703

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 088703
Product	Strength	Form · route	Labeler	Product NDC
PredniSONE	Prednisone 5 mg/5mL	SolutionOral	Atlantic Biologicals Corps	17856-3722