What is NDC 80425-0491?

80425-0491 is the product NDC for Prednisone, Prednisone 10 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Prednisone?

281 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Prednisone NDC 80425-0491 | National Drug Code

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	8042504910180425049101	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, LLCNDC labeler code 80425
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)

About NDC 80425-0491

What is NDC 80425-0491?: 80425-0491 is the product NDC for Prednisone, Prednisone 10 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Prednisone.
What is the active ingredient?: Prednisone.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Prednisone?: 281 other product NDCs are listed under this name. See all Prednisone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Prednisone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
PredniSONE	Prednisone 10 mg/1	TabletOral	Coupler LLC	67046-1294	67046-1294-03
PredniSONE	Prednisone 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4182	68788-4182-0168788-4182-0268788-4182-03+3 more
prednisone	Prednisone 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-069	87441-0069-01
prednisone	Prednisone 50 mg/1	TabletOral	Coupler LLC	67046-1171	67046-1171-03
prednisone	Prednisone 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2582	55154-2582-00
prednisone	Prednisone 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4660	70518-4660-00
Prednisone	Prednisone 50 mg/1	TabletOral	Coupler LLC	67046-1379	67046-1379-03
Prednisone	Prednisone 20 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2581	55154-2581-00
Prednisone	Prednisone 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4560	70518-4560-00
prednisone	Prednisone 5 mg/1	TabletOral	American Health Packaging	60687-903	60687-0903-01

All 282 Prednisone NDCs

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	Prednisone 10 mg/1	TabletOral	QPharma, Inc.	42708-115
Prednisone	Prednisone 10 mg/1	TabletOral	Northwind Health Company, LLC	51655-410
Prednisone	Prednisone 10 mg/1	TabletOral	Redpharm Drug	67296-0140
Prednisone	Prednisone 10 mg/1	TabletOral	Proficient Rx LP	71205-362
Prednisone D/P	Prednisone 10 mg/1	TabletOral	Direct_Rx	72189-646