Prescription drug · NDA
Xtandi (Enzalutamide) NDC 0469-0625
Enzalutamide 40 mg/1 · Tablet · Oral · Astellas Pharma US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0469-0625-99 | 0046906259900469062599 | 1 BOTTLE in 1 CARTON (0469-0625-99) / 120 TABLET in 1 BOTTLEMarketed from Aug 4, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Xtandi
- Generic name (nonproprietary)
- enzalutamide
- Active ingredients
- Enzalutamide — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Astellas Pharma US, Inc.NDC labeler code 0469
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213674
- Marketing start
- Listing expires
- Other FDA classes
- Androgen Receptor Antagonists (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)
- Identifiers
- Product ID 0469-0625_1cc0ed2a-2c33-4027-90bb-572d717b81d2SPL ID 1cc0ed2a-2c33-4027-90bb-572d717b81d2SPL set ID b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdfRxCUI 1307303, 1307309, 2390644, 2390646, 2390648, 2390650UNII 93T0T9GKNUUPC 0304690125990, 0304690725602
- Pharmacologic class
- Androgen Receptor 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
N400469062599followed by a unit qualifier and the quantityPackage 00469-0625-99. 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)
XTANDI ® is indicated for the treatment of patients with: • castration-resistant prostate cancer (CRPC) • metastatic castration-sensitive prostate cancer (mCSPC) • non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: • castration-resistant prostate cancer. ( 1 ) • metastatic castration-sensitive prostate cancer. ( 1 ) • non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0469-0625
- What is NDC 0469-0625?
- 0469-0625 is the product NDC for Xtandi (enzalutamide), Enzalutamide 40 mg/1 tablet, listed with the FDA by Astellas Pharma US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xtandi (Enzalutamide).
- What is the active ingredient?
- Enzalutamide.
- Who is the labeler?
- Astellas Pharma US, Inc., NDC labeler code 0469. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xtandi?
- 4 other product NDCs are listed under this name. See all Xtandi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xtandi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xtandienzalutamide | Enzalutamide 80 mg/1 | TabletOral | Astellas Pharma US, Inc. | 0469-0725 | 00469-0725-60 |
| Xtandienzalutamide | Enzalutamide 40 mg/1 | TabletOral | Astellas Pharma US, Inc. | 0469-1725 | 00469-1725-56 |
| Xtandienzalutamide | Enzalutamide 40 mg/1 | CapsuleOral | Astellas Pharma US, Inc. | 0469-0125 | 00469-0125-99 |
| Xtandienzalutamide | Enzalutamide 40 mg/1 | CapsuleOral | Astellas Pharma US, Inc. | 0469-1125 | 00469-1125-56 |
Other NDCs under NDA 213674
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 |
|---|---|---|---|---|
| Xtandienzalutamide | Enzalutamide 80 mg/1 | TabletOral | Astellas Pharma US, Inc. | 0469-0725 |
| Xtandienzalutamide | Enzalutamide 40 mg/1 | TabletOral | Astellas Pharma US, Inc. | 0469-1725 |