Prednisolone NDC 42658-160

NDC codes

FDA NDC Directory

Product NDC (as listed)42658-160Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42658-0160Add 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
42658-160-05	42658016005	100 TABLET in 1 BOTTLE (42658-160-05)Marketed from Sep 1, 2024

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): Prednisolone
Generic name (nonproprietary): prednisolone
Active ingredients: Prednisolone — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hisun Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218083
Marketing start: Sep 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 42658-160_9f93400d-a8c0-435a-ad65-48717cc455cfSPL ID 9f93400d-a8c0-435a-ad65-48717cc455cfSPL set ID 16d4e064-66d3-4497-8c7d-3aa355f91e1dRxCUI 198142UNII 9PHQ9Y1OLMUPC 0342658160058
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

N442658016005 followed by a unit qualifier and the quantity

Package 42658-0160-05. 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 Aug 15, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218083

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

FDA NDC Directory listings under ANDA 218083
Product	Strength	Form · route	Labeler	Product NDC
Prednisolone	Prednisolone 5 mg/1	TabletOral	Zhejiang Xianju Pharmaceutical Co., Ltd.	60722-5011