Prednisone NDC 0603-5336

NDC codes

FDA NDC Directory

Product NDC (as listed)0603-5336Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00603-5336Add 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
0603-5336-21	00603533621	100 TABLET in 1 BOTTLE, PLASTIC (0603-5336-21)Marketed from Dec 21, 2004

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Par Health USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040581
Marketing start: Dec 21, 2004
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0603-5336_68bdeba1-553d-4d18-ae66-5eb8a0a880b8SPL ID 68bdeba1-553d-4d18-ae66-5eb8a0a880b8SPL set ID 10fe5a3b-84dc-4600-87c2-b80c97ce18cfRxCUI 198144, 198145, 198146, 312615, 312617, 763179, 763181, 763183, 763185UNII VB0R961HZTUPC 0306035338317, 0306035337211, 0306035338157, 0306035335217, 0306035336214, 0306035337310, 0306035338218
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

N400603533621 followed by a unit qualifier and the quantity

Package 00603-5336-21. 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 Jul 31, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE PredniSONE Tablets 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 cases …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040581

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

FDA NDC Directory listings under ANDA 040581
Product	Strength	Form · route	Labeler	Product NDC
Prednisone	Prednisone 2.5 mg/1	TabletOral	Bryant Ranch Prepack	63629-2260
Prednisone	Prednisone 2.5 mg/1	TabletOral	Northwind Health Company, LLC	51655-197
Prednisone	Prednisone 2.5 mg/1	TabletOral	Coupler LLC	67046-1448