Prescription drug · ANDA
Ursodiol NDC 50268-864
Ursodiol 300 mg/1 · Capsule · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-864-13 | 50268086413 | 30 BLISTER PACK in 1 BOX (50268-864-13) / 1 CAPSULE in 1 BLISTER PACK (50268-864-11)Marketed from Jul 14, 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)
- Ursodiol
- Generic name (nonproprietary)
- ursodiol
- Active ingredients
- Ursodiol — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214295
- Marketing start
- Listing expires
- Other FDA classes
- Bile Acids and Salts (Chemical structure)
- Identifiers
- Product ID 50268-864_5797b1d5-e686-ba35-e063-6294a90adae6SPL ID 5797b1d5-e686-ba35-e063-6294a90adae6SPL set ID 5693d709-e894-0144-e063-6294a90a99dbRxCUI 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
N450268086413followed by a unit qualifier and the quantityPackage 50268-0864-13. 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 1. 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. 2. 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.
Other NDCs under ANDA 214295
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.