NDC codes

FDA NDC Directory
Product NDC (as listed)81279-130Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81279-0130Add 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
81279-130-60812790130608127901306060 CAPSULE in 1 BOTTLE (81279-130-60)Marketed from Jun 15, 2026

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)
Ursolign
Generic name (nonproprietary)
ursodiol
Active ingredients
Ursodiol — 150 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Pangea Pharmaceuticals, LLCNDC labeler code 81279
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210344
Marketing start
Listing expires
Other FDA classes
Bile Acids and Salts (Chemical structure)
Identifiers
Product ID 81279-130_5e248968-a19d-4b59-9873-fba89f6b7fb1SPL ID 5e248968-a19d-4b59-9873-fba89f6b7fb1SPL set ID 3617fb7a-1f57-4276-bebb-ae6ba4252d4eRxCUI 858331, 2745304UNII 724L30Y2QRUPC 0381279130606
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

N481279013060 followed by a unit qualifier and the quantity

Package 81279-0130-60. 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 URSOLIGN TM is 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 URSOLIGN TM beyond 24 months is not established. URSOLIGN TM is 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 81279-130

What is NDC 81279-130?
81279-130 is the product NDC for Ursolign (ursodiol), Ursodiol 150 mg/1 capsule, listed with the FDA by Pangea Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ursolign (Ursodiol).
What is the active ingredient?
Ursodiol.
Who is the labeler?
Pangea Pharmaceuticals, LLC, NDC labeler code 81279. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ursolign?
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 ANDA 210344

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

FDA NDC Directory listings under ANDA 210344
ProductStrengthForm · routeLabelerProduct NDC
UrsodiolUrsodiol 300 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-754
UrsodiolUrsodiol 300 mg/1CapsuleOralStrides Pharma Science Limited64380-844

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