Prescription drug · NDA
Odomzo (sonidegib) NDC 47335-303
Sonidegib phosphate 200 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-303-15 | 47335030315 | 30 CAPSULE in 1 BOTTLE (47335-303-15)Marketed from Sep 21, 2017 | |
| 47335-303-83 | 47335030383 | 30 CAPSULE in 1 BOTTLE (47335-303-83)Marketed from Sep 21, 2017 |
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)
- Odomzo
- Generic name (nonproprietary)
- sonidegib
- Active ingredients
- Sonidegib phosphate — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205266
- Marketing start
- Listing expires
- Other FDA classes
- Smoothened Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 47335-303_001dc6f2-7476-4ffd-8ea4-be2f97a2b6b3SPL ID 001dc6f2-7476-4ffd-8ea4-be2f97a2b6b3SPL set ID 028312dc-d155-4fd5-8abd-6bb9f011d3ccRxCUI 1659921, 1659927UNII W421AI34UW
- Pharmacologic class
- Hedgehog Pathway Inhibitor
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
N447335030315followed by a unit qualifier and the quantityPackage 47335-0303-15. 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)
ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. ODOMZO is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. ( 1 )
Excerpt only. Read the full label for complete information.