What is NDC 42291-931?

42291-931 is the product NDC for Ursodiol, Ursodiol 500 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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 42291-931 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-931Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0931Add 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
42291-931-01	42291093101	100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01)Marketed from Dec 14, 2023

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 — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202540
Marketing start: Dec 14, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 42291-931_48c0d20b-d59e-c74b-e063-6394a90a1f3fSPL ID 48c0d20b-d59e-c74b-e063-6394a90a1f3fSPL set ID 0c7e1aa2-704c-435d-e063-6394a90a2d08RxCUI 858733UNII 724L30Y2QRUPC 0342291931015
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

N442291093101 followed by a unit qualifier and the quantity

Package 42291-0931-01. 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 19, 2026.

Indications (excerpt from the label)

Ursodiol Tablets, USP are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Ursodiol tablets, USP are bile acids indicated for the treatment of patients with primary biliary cirrhosis ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-931

What is NDC 42291-931?: 42291-931 is the product NDC for Ursodiol, Ursodiol 500 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, 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?: AvKARE, NDC labeler code 42291. 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 300 mg/1	CapsuleOral	AvKARE	42291-923	42291-0923-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-421	59651-0421-01
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2619	72162-2619-01
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
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	AvPAK	50268-797	50268-0797-15

All 44 Ursodiol NDCs

Other NDCs under ANDA 202540

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

FDA NDC Directory listings under ANDA 202540
Product	Strength	Form · route	Labeler	Product NDC
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2633
Ursodiol	Ursodiol 500 mg/1	Tablet, Film coatedOral	Par Health USA, LLC	49884-413
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Par Health USA, LLC	49884-412
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-2286
Ursodiol	Ursodiol 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-2287
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1500
Ursodiol	Ursodiol 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1501
Ursodiol	Ursodiol 250 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6890