What is NDC 0527-5406?

0527-5406 is the product NDC for PrednisoLONE, Prednisolone 15 mg/5mL syrup, listed with the FDA by Lannett Company, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Lannett Company, Inc., NDC labeler code 0527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for PrednisoLONE?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

PrednisoLONE NDC 0527-5406 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-5406Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-5406Add 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
0527-5406-68	00527540668	240 mL in 1 BOTTLE (0527-5406-68)Marketed from Sep 21, 2007
0527-5406-70	00527540670	480 mL in 1 BOTTLE (0527-5406-70)Marketed from Sep 21, 2007

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): PrednisoLONE
Generic name (nonproprietary): prednisolone
Active ingredients: Prednisolone — 15 mg/5mL
Dosage form: Syrup
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 0527
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040775
Marketing start: Sep 21, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0527-5406_5122ba73-5783-49f0-9b9c-a03d59d8899cSPL ID 5122ba73-5783-49f0-9b9c-a03d59d8899cSPL set ID 86652e2d-664a-4388-a611-c2a9aa4a4bc8RxCUI 283077UNII 9PHQ9Y1OLM
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

N400527540668 followed by a unit qualifier and the quantity

Package 00527-5406-68. 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 Feb 14, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Prednisolone Syrup (Prednisolone Oral Solution, USP) is 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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 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 rhe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0527-5406

What is NDC 0527-5406?: 0527-5406 is the product NDC for PrednisoLONE, Prednisolone 15 mg/5mL syrup, listed with the FDA by Lannett Company, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: PrednisoLONE.
What is the active ingredient?: Prednisolone.
Who is the labeler?: Lannett Company, Inc., NDC labeler code 0527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for PrednisoLONE?: 11 other product NDCs are listed under this name. See all PrednisoLONE 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 PrednisoLONE NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Prednisoloneprednisolone oral	Prednisolone 15 mg/5mL	SolutionOral	TRUPHARMA, LLC	52817-860	52817-0860-0852817-0860-16
Prednisoloneprednisolone oral	Prednisolone 15 mg/5mL	SolutionOral	Tulex Pharmaceuticals Inc	70404-077	70404-0077-1470404-0077-16
Prednisoloneprednisolone oral solution	Prednisolone 15 mg/5mL	SolutionOral	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	23155-927	23155-0927-5123155-0927-52
Prednisolone	Prednisolone 5 mg/1	TabletOral	Hisun Pharmaceuticals USA, Inc.	42658-160	42658-0160-05
Prednisolone	Prednisolone 5 mg/1	TabletOral	Zhejiang Xianju Pharmaceutical Co., Ltd.	60722-5011	60722-5011-0060722-5011-01
Prednisolone	Prednisolone 15 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0885	00121-0885-0800121-0885-16
Prednisolone	Prednisolone 15 mg/5mL	SolutionOral	A-S Medication Solutions	50090-7115	50090-7115-0050090-7115-01
Prednisolone	Prednisolone 5 mg/1	TabletOral	Aurobindo Pharma Limited	59651-491	59651-0491-0159651-0491-50
Prednisoloneprednisolone oral	Prednisolone 15 mg/5mL	SolutionOral	Chartwell Governmental & Specialty RX, LLC.	68999-250	68999-0250-24
Prednisoloneprednisolone oral	Prednisolone 15 mg/5mL	SolutionOral	Chartwell RX, LLC	62135-250	62135-0250-2462135-0250-3762135-0250-47

All 12 PrednisoLONE NDCs