Prednisone NDC 80425-0491

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0491Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0491Add 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
80425-0491-1	80425049101	1 BLISTER PACK in 1 CARTON (80425-0491-1) / 21 TABLET in 1 BLISTER PACKMarketed from Mar 17, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 085162
Marketing start: Mar 17, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 80425-0491_309580ae-7ca3-e291-e063-6394a90adbc7SPL ID 309580ae-7ca3-e291-e063-6394a90adbc7SPL set ID 309580a7-c3bb-e53b-e063-6394a90a1563RxCUI 198145UNII VB0R961HZT
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

N480425049101 followed by a unit qualifier and the quantity

Package 80425-0491-01. 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 Mar 17, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Prednisone tablets, USP are indicated in the following conditions: 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. 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 085162

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

FDA NDC Directory listings under ANDA 085162
Product	Strength	Form · route	Labeler	Product NDC
Prednisone D/P	Prednisone 10 mg/1	TabletOral	Direct_Rx	72189-646
Prednisone	Prednisone 10 mg/1	TabletOral	Proficient Rx LP	71205-362
Prednisone	Prednisone 10 mg/1	TabletOral	Actavis Pharma, Inc.	0591-5442
Prednisone	Prednisone 10 mg/1	TabletOral	Redpharm Drug	67296-0140
Prednisone	Prednisone 10 mg/1	TabletOral	Northwind Health Company, LLC	51655-410
Prednisone	Prednisone 10 mg/1	TabletOral	QPharma, Inc.	42708-115