Prescription drug · NDA
Yonsa (Abiraterone acetate) NDC 47335-401
Abiraterone acetate 125 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-401-81 | 4733504018147335040181 | 120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81)Marketed from May 22, 2018 |
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)
- Yonsa
- Generic name (nonproprietary)
- abiraterone acetate
- Active ingredients
- Abiraterone acetate — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210308
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 17A1 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-401_7cc706b3-7d39-405d-91a4-5a7d433b4d2fSPL ID 7cc706b3-7d39-405d-91a4-5a7d433b4d2f
- Pharmacologic class
- Cytochrome P450 17A1 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
N447335040181followed by a unit qualifier and the quantityPackage 47335-0401-81. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 47335-401
- What is NDC 47335-401?
- 47335-401 is the product NDC for Yonsa (abiraterone acetate), Abiraterone acetate 125 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Yonsa (Abiraterone acetate).
- What is the active ingredient?
- Abiraterone acetate.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Yonsa?
- 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.
Other NDCs under NDA 210308
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 |
|---|---|---|---|---|
| Abiraterone Acetate | Abiraterone acetate 125 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-503 |