Prescription drug · ANDA
Ursodiol NDC 68001-378
Ursodiol 500 mg/1 · Tablet · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-378-00 | 68001037800 | 100 TABLET in 1 BOTTLE (68001-378-00)Marketed from Feb 26, 2019 |
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 — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090801
- Marketing start
- Listing expires
- Other FDA classes
- Bile Acids and Salts (Chemical structure)
- Identifiers
- Product ID 68001-378_568f3b26-3cb8-19ba-e063-6394a90a8175SPL ID 568f3b26-3cb8-19ba-e063-6394a90a8175SPL set ID a3c98080-0a4d-4a93-8dcb-02ab8533050bRxCUI 858733, 858751UNII 724L30Y2QRUPC 0368001378000, 0368001377003
- 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
N468001037800followed by a unit qualifier and the quantityPackage 68001-0378-00. 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 , 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC). Ursodiol tablets, 250 mg and 500 mg are bile acids indicated for the treatment of patients with primary biliary cholangitis. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090801
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 250 mg/1 | TabletOral | BluePoint Laboratories | 68001-377 |
| Ursodiol | Ursodiol 250 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-473 |
| Ursodiol | Ursodiol 500 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-474 |