Prescription drug · ANDA
Chenodal (Chenodiol) NDC 68974-876
Chenodiol 250 mg/1 · Tablet, Film coated · Oral · Travere Therapeutics
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68974-876-40 | 68974087640 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68974-876-40)Marketed from Dec 28, 2015 |
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)
- Chenodal
- Generic name (nonproprietary)
- chenodiol
- Active ingredients
- Chenodiol — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Travere TherapeuticsNDC labeler code 68974
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091019
- Marketing start
- Marketing end
- Other FDA classes
- Bile Acids and Salts (Chemical structure)
- Identifiers
- Product ID 68974-876_45c74545-e0d8-e34f-e063-6294a90ae857SPL ID 45c74545-e0d8-e34f-e063-6294a90ae857SPL set ID 769e0a3b-826d-4faf-9129-5eeb7ebe0b67RxCUI 618469, 877417UNII 0GEI24LG0J
- 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
N468974087640followed by a unit qualifier and the quantityPackage 68974-0876-40. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Chenodiol is indicated for patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age. The likelihood of successful dissolution is far greater if the stones are floatable or small. For patients with nonfloatable stones, dissolution is less likely and added weight should be given to the risk that more emergent surgery might result form a delay due to unsuccessful treatment. Safety of use beyond 24 months is not established. Chenodiol will not dissolve calcified (radiopaque) or radiolucent bile pigment stones.
Excerpt only. Read the full label for complete information.
About NDC 68974-876
- What is NDC 68974-876?
- 68974-876 is the product NDC for Chenodal (chenodiol), Chenodiol 250 mg/1 tablet, film coated, listed with the FDA by Travere Therapeutics. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chenodal (Chenodiol).
- What is the active ingredient?
- Chenodiol.
- Who is the labeler?
- Travere Therapeutics, NDC labeler code 68974. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chenodal?
- 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.