Prescription drug · ANDA
Ursodiol NDC 72162-1501
Ursodiol 500 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1501-1 | 72162150101 | 100 TABLET, FILM COATED in 1 BOTTLE (72162-1501-1)Marketed from Mar 30, 2023 |
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 — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202540
- Marketing start
- Listing expires
- Other FDA classes
- Bile Acids and Salts (Chemical structure)
- Identifiers
- Product ID 72162-1501_ef4f0687-2fd1-43b2-9c55-e678cadb53d1SPL ID ef4f0687-2fd1-43b2-9c55-e678cadb53d1SPL set ID be811c61-5f48-4b03-94b6-e6941b595621RxCUI 858733UNII 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
N472162150101followed by a unit qualifier and the quantityPackage 72162-1501-01. 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)
Ursodiol Tablets, USP are indicated for the treatment of patients with primary biliary cirrhosis (PBC). Ursodiol tablets, USP are bile acids indicated for the treatment of patients with primary biliary cirrhosis ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202540
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 500 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-931 |
| Ursodiol | Ursodiol 500 mg/1 | Tablet, Film coatedOral | Par Health USA, LLC | 49884-413 |
| Ursodiol | Ursodiol 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2287 |
| Ursodiol | Ursodiol 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2286 |
| Ursodiol | Ursodiol 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1500 |
| Ursodiol | Ursodiol 250 mg/1 | Tablet, Film coatedOral | Par Health USA, LLC | 49884-412 |
| Ursodiol | Ursodiol 250 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6890 |
| Ursodiol | Ursodiol 250 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2633 |