Prescription drug · ANDA
Ursolign (Ursodiol) NDC 81279-130
Ursodiol 150 mg/1 · Capsule · Oral · Pangea Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81279-130-60 | 8127901306081279013060 | 60 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
N481279013060followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ursodiol | Ursodiol 300 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-754 |
| Ursodiol | Ursodiol 300 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-844 |