What is NDC 0054-0017?

0054-0017 is the product NDC for PredniSONE, Prednisone 10 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 0054-0017 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0017Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0017Add 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
0054-0017-20	0005400172000054001720	10 BLISTER PACK in 1 CARTON (0054-0017-20) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 13, 2003
0054-0017-25	0005400172500054001725	100 TABLET in 1 BOTTLE, PLASTIC (0054-0017-25)Marketed from Feb 13, 2003
0054-0017-29	0005400172900054001729	500 TABLET in 1 BOTTLE, PLASTIC (0054-0017-29)Marketed from Feb 13, 2003

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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 080352
Marketing start: Feb 13, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0054-0017_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

N400054001720 followed by a unit qualifier and the quantity

Package 00054-0017-20. 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)

About NDC 0054-0017

What is NDC 0054-0017?: 0054-0017 is the product NDC for PredniSONE, Prednisone 10 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 3 package NDCs, 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 080352

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

FDA NDC Directory listings under ANDA 080352
Product	Strength	Form · route	Labeler	Product NDC
PredniSONE	Prednisone 20 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0018
PredniSONE	Prednisone 50 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0019
PredniSONE	Prednisone 5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-4728
PredniSONE	Prednisone 1 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-4741
PredniSONE	Prednisone 2.5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-4742
PredniSONE	Prednisone 5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-8724
PredniSONE	Prednisone 1 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-8739
PredniSONE	Prednisone 2.5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-8740
PredniSONE	Prednisone 10 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-9817
PredniSONE	Prednisone 20 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-9818
PredniSONE	Prednisone 5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-9828
PredniSONE	Prednisone 5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-968
PredniSONE	Prednisone 5 mg/1	TabletOral	A-S Medication Solutions	50090-6619
PredniSONE	Prednisone 5 mg/1	TabletOral	A-S Medication Solutions	50090-6621
PredniSONE	Prednisone 5 mg/1	TabletOral	A-S Medication Solutions	50090-6623
PredniSONE	Prednisone 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-355
PredniSONE	Prednisone 10 mg/1	TabletOral	Northwind Health Company, LLC	51655-726
PredniSONE	Prednisone 5 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-796
PredniSONE	Prednisone 10 mg/1	TabletOral	Coupler LLC	67046-1294
PredniSONE	Prednisone 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3581

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