NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2619Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2619Add 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 NDC11-digit (billing)PackageCopy
72162-2619-172162261901100 CAPSULE in 1 BOTTLE (72162-2619-1)Marketed from Apr 20, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Bryant Ranch PrepackNDC labeler code 72162
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214849
Marketing start
Listing expires
Other FDA classes
Bile Acids and Salts (Chemical structure)
Identifiers
Product ID 72162-2619_b47f9107-f568-442b-9025-647dc6b49cebSPL ID b47f9107-f568-442b-9025-647dc6b49cebSPL set ID b2605f6a-b72d-4773-8d2c-39acfe81e424RxCUI 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

N472162261901 followed by a unit qualifier and the quantity

Package 72162-2619-01. 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 .

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 72162-2619

What is NDC 72162-2619?
72162-2619 is the product NDC for Ursodiol, Ursodiol 300 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 72162. 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?
41 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
UrsodiolUrsodiol 300 mg/1CapsuleOralAvPAK50268-86450268-0864-13
UrsodiolUrsodiol 300 mg/1CapsuleOralNorthStar Rx LLC72603-61372603-0613-01
UrsodiolUrsodiol 250 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-263355154-2633-00
UrsodiolUrsodiol 500 mg/1Tablet, Film coatedOralAvKARE42291-93142291-0931-01
UrsodiolUrsodiol 300 mg/1CapsuleOralAvKARE42291-92342291-0923-01
UrsodiolUrsodiol 300 mg/1CapsuleOralPuraCap Laboratories, LLC24658-99924658-0999-10
UrsodiolUrsodiol 300 mg/1CapsuleOralStrides Pharma Science Limited64380-84464380-0844-0464380-0844-0664380-0844-07
UrsodiolUrsodiol 300 mg/1CapsuleOralLaurus Labs Limited42385-94642385-0946-01
UrsodiolUrsodiol 300 mg/1CapsuleOralAvPAK50268-79750268-0797-15
UrsodiolUrsodiol 250 mg/1TabletOralStrides Pharma Science Limited64380-91864380-0918-06

All 42 Ursodiol NDCs

Other NDCs under ANDA 214849

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

FDA NDC Directory listings under ANDA 214849
ProductStrengthForm · routeLabelerProduct NDC
UrsodiolUrsodiol 300 mg/1CapsuleOralAurobindo Pharma Limited59651-421
UrsodiolUrsodiol 300 mg/1CapsuleOralNorthStar Rx LLC72603-613

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