Ursodiol NDC 72664-217

NDC codes

FDA NDC Directory

Product NDC (as listed)72664-217Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72664-0217Add 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
72664-217-01	72664021701	100 CAPSULE in 1 BOTTLE, PLASTIC (72664-217-01)Marketed from Oct 25, 2020

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: VGYAAN Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214329
Marketing start: Oct 25, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 72664-217_062ebe65-b4e7-2fb9-e063-6294a90a5caaSPL ID 062ebe65-b4e7-2fb9-e063-6294a90a5caaSPL set ID db43354d-4d77-4241-af4e-5cfa6f6cd296RxCUI 858747UNII 724L30Y2QRUPC 0372664217019
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

N472664021701 followed by a unit qualifier and the quantity

Package 72664-0217-01. 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 Sep 25, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ursodiol capsules are 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 capsules beyond 24 months is not established. Ursodiol capsules are 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)