What is NDC 58914-785?

58914-785 is the product NDC for Urso 250 (ursodiol), Ursodiol 250 mg/1 tablet, film coated, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Allergan, Inc., NDC labeler code 58914. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Urso 250?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Urso 250 NDC 58914-785 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58914-785Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58914-0785Add 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
58914-785-10	58914078510	100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10)Marketed from Dec 10, 1997

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): Urso 250
Generic name (nonproprietary): ursodiol
Active ingredients: Ursodiol — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Allergan, Inc.NDC labeler code 58914
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020675
Marketing start: Dec 10, 1997
Listing expires: Dec 31, 2026
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 58914-785_06904c03-cea9-4532-8e27-7f2246be613bSPL ID 06904c03-cea9-4532-8e27-7f2246be613bSPL set ID e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61RxCUI 858733, 858735, 858751, 858752UNII 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

N458914078510 followed by a unit qualifier and the quantity

Package 58914-0785-10. 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 Jan 12, 2023.

Indications (excerpt from the label)

URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC). URSO 250 and URSO Forte (ursodiol) tablets are bile acids indicated for the treatment of patients with primary biliary cholangitis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58914-785

What is NDC 58914-785?: 58914-785 is the product NDC for Urso 250 (ursodiol), Ursodiol 250 mg/1 tablet, film coated, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Urso 250 (Ursodiol).
What is the active ingredient?: Ursodiol.
Who is the labeler?: Allergan, Inc., NDC labeler code 58914. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Urso 250?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 020675

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

FDA NDC Directory listings under NDA 020675
Product	Strength	Form · route	Labeler	Product NDC
Urso Forteursodiol	Ursodiol 500 mg/1	Tablet, Film coatedOral	Allergan, Inc.	58914-790

Urso 250 (Ursodiol) NDC 58914-785