What is NDC 68462-473?

68462-473 is the product NDC for Ursodiol, Ursodiol 250 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ursodiol?

43 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ursodiol NDC 68462-473 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-473Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0473Add 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
68462-473-01	6846204730168462047301	100 TABLET in 1 BOTTLE (68462-473-01)Marketed from Jul 12, 2011
68462-473-05	6846204730568462047305	500 TABLET in 1 BOTTLE (68462-473-05)Marketed from Jul 12, 2011
68462-473-30	6846204733068462047330	30 TABLET in 1 BOTTLE (68462-473-30)Marketed from Jul 12, 2011

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 — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090801
Marketing start: Jul 12, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 68462-473_71c17751-51cb-411d-b90b-4b98ad4a768eSPL ID 71c17751-51cb-411d-b90b-4b98ad4a768eSPL set ID fb79b62a-b450-4d7a-be28-5ee4d174fd58RxCUI 858733, 858751UNII 724L30Y2QRUPC 0368462474013, 0368462473016
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

N468462047301 followed by a unit qualifier and the quantity

Package 68462-0473-01. 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 Jan 27, 2026.

Indications (excerpt from the label)

Ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC). Ursodiol tablets, 250 mg and 500 mg 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 68462-473

What is NDC 68462-473?: 68462-473 is the product NDC for Ursodiol, Ursodiol 250 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ursodiol.
What is the active ingredient?: Ursodiol.
Who is the labeler?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ursodiol?: 43 other product NDCs are listed under this name. See all Ursodiol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ursodiol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	AvPAK	50268-864	50268-0864-13
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	NorthStar Rx LLC	72603-613	72603-0613-01
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2633	55154-2633-00
Ursodiol	Ursodiol 500 mg/1	Tablet, Film coatedOral	AvKARE	42291-931	42291-0931-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	AvKARE	42291-923	42291-0923-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2619	72162-2619-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-421	59651-0421-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	PuraCap Laboratories, LLC	24658-999	24658-0999-10
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Strides Pharma Science Limited	64380-844	64380-0844-0464380-0844-0664380-0844-07
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Laurus Labs Limited	42385-946	42385-0946-01

All 44 Ursodiol NDCs

Other NDCs under ANDA 090801

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

FDA NDC Directory listings under ANDA 090801
Product	Strength	Form · route	Labeler	Product NDC
Ursodiol	Ursodiol 250 mg/1	TabletOral	BluePoint Laboratories	68001-377
Ursodiol	Ursodiol 500 mg/1	TabletOral	BluePoint Laboratories	68001-378
Ursodiol	Ursodiol 500 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-474