Prednisone NDC 54348-506

NDC codes

FDA NDC Directory

Product NDC (as listed)54348-506Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54348-0506Add 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
54348-506-10	54348050610	1 BOTTLE in 1 BOX (54348-506-10) / 10 TABLET in 1 BOTTLEMarketed from Jul 12, 2019
54348-506-20	54348050620	1 BOTTLE in 1 BOX (54348-506-20) / 20 TABLET in 1 BOTTLEMarketed from Jul 12, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: PharmPak, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 080356
Marketing start: Jul 12, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 54348-506_ea92f170-7889-dd0d-e053-2a95a90a80f0SPL ID ea92f170-7889-dd0d-e053-2a95a90a80f0SPL set ID 03aaf69f-d9c7-433c-baea-9c6eca0fe1e5RxCUI 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

N454348050610 followed by a unit qualifier and the quantity

Package 54348-0506-10. 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 Oct 8, 2022.

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 080356

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

FDA NDC Directory listings under ANDA 080356
Product	Strength	Form · route	Labeler	Product NDC
Prednisone	Prednisone 5 mg/1	TabletOral	Actavis Pharma, Inc.	0591-5052
Prednisone	Prednisone 5 mg/1	TabletOral	Proficient Rx LP	63187-997
Prednisone	Prednisone 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-3537
Prednisone	Prednisone 5 mg/1	TabletOral	QPharma, Inc.	42708-114