Ursodiol NDC 42806-503

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-503Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0503Add 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
42806-503-01	42806050301	100 CAPSULE in 1 BOTTLE (42806-503-01)Marketed from Jul 16, 2010

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): Ursodiol
Generic name (nonproprietary): ursodiol
Active ingredients: Ursodiol — 300 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Epic Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075517
Marketing start: Jul 16, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 42806-503_392c277e-5bc5-46c7-b2f2-8b48baaa6f83SPL ID 392c277e-5bc5-46c7-b2f2-8b48baaa6f83SPL set ID e47b49ca-bde9-448a-bf61-f943c2aa5b8eRxCUI 858747UNII 724L30Y2QRUPC 0342806503010
Pharmacologic class: Bile Acid

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

N442806050301 followed by a unit qualifier and the quantity

Package 42806-0503-01. 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 Aug 10, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE 1. Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. 2. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075517

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

FDA NDC Directory listings under ANDA 075517
Product	Strength	Form · route	Labeler	Product NDC
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Major Pharmaceuticals	0904-6221
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	PuraCap Laboratories, LLC	24658-780
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	PuraCap Laboratories, LLC	24658-999
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2168