What is NDC 50268-797?

50268-797 is the product NDC for Ursodiol, Ursodiol 300 mg/1 capsule, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. 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 50268-797 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-797Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0797Add 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
50268-797-15	5026807971550268079715	50 BLISTER PACK in 1 BOX (50268-797-15) / 1 CAPSULE in 1 BLISTER PACK (50268-797-11)Marketed from Feb 19, 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
Generic name (nonproprietary): ursodiol
Active ingredients: Ursodiol — 300 mg/1
Dosage form: Capsule
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211301
Marketing start: Feb 19, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 50268-797_48378beb-66aa-975e-e063-6294a90a0aeeSPL ID 48378beb-66aa-975e-e063-6294a90a0aeeSPL set ID bbb1f297-1536-9550-e053-2995a90a0d41RxCUI 858747UNII 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

N450268079715 followed by a unit qualifier and the quantity

Package 50268-0797-15. 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, 2026.

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)

About NDC 50268-797

What is NDC 50268-797?: 50268-797 is the product NDC for Ursodiol, Ursodiol 300 mg/1 capsule, listed with the FDA by AvPAK. 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?: AvPAK, NDC labeler code 50268. 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 211301

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

FDA NDC Directory listings under ANDA 211301
Product	Strength	Form · route	Labeler	Product NDC
Ursodiol	Ursodiol 300 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1540