Ursodiol 400 mg (ursodiol) NDC 72887-144

NDC codes

FDA NDC Directory

Product NDC (as listed)72887-144Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72887-0144Add 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
72887-144-06	72887014406	60 CAPSULE in 1 BOTTLE (72887-144-06)Marketed from Nov 18, 2021

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 400 mg
Generic name (nonproprietary): ursodiol
Active ingredients: Ursodiol — 400 mg/1
Dosage form: Capsule
Route: Oral
Labeler: FH2 Pharma LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205789
Marketing start: Nov 18, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 72887-144_c28d41e2-14c2-4401-87ab-49b32239cabaSPL ID c28d41e2-14c2-4401-87ab-49b32239cabaSPL set ID 476179dc-b410-4305-881b-470511765647RxCUI 412174, 2376942UNII 724L30Y2QR
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

N472887014406 followed by a unit qualifier and the quantity

Package 72887-0144-06. 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 Dec 31, 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 205789

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

FDA NDC Directory listings under ANDA 205789
Product	Strength	Form · route	Labeler	Product NDC
Reltone 200 mgursodiol	Ursodiol 200 mg/1	CapsuleOral	Intra-Sana Laboratories	80056-143
Reltone 400 mgursodiol	Ursodiol 400 mg/1	CapsuleOral	Intra-Sana Laboratories	80056-144
Ursodiol 200 mgursodiol	Ursodiol 200 mg/1	CapsuleOral	FH2 Pharma LLC	72887-143
Ursodiol 200 mgusodiol	Ursodiol 200 mg/1	CapsuleOral	LGM PHARMA SOLUTIONS, LLC	79739-7143
Ursodiol 400 mgusodiol	Ursodiol 400 mg/1	CapsuleOral	LGM PHARMA SOLUTIONS, LLC	79739-7144