Prescription drug · NDA
Veozah (Fezolinetant) NDC 0469-2660
Fezolinetant 45 mg/1 · Tablet, Film coated · Oral · Astellas Pharma US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0469-2660-30 | 0046926603000469266030 | 1 BOTTLE in 1 CARTON (0469-2660-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from May 12, 2023 | |
| 0469-2660-90 | 0046926609000469266090 | 1 BOTTLE in 1 CARTON (0469-2660-90) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from May 12, 2023 |
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)
- Veozah
- Generic name (nonproprietary)
- fezolinetant
- Active ingredients
- Fezolinetant — 45 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Astellas Pharma US, Inc.NDC labeler code 0469
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216578
- Marketing start
- Listing expires
- Other FDA classes
- Neurokinin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0469-2660_462f0a23-98d6-4154-b113-322008069743SPL ID 462f0a23-98d6-4154-b113-322008069743SPL set ID cae9f798-24f9-4580-a4fc-e6c710cbda3cRxCUI 2637141, 2637147UNII 83VNE45KXX
- Pharmacologic class
- Neurokinin 3 Receptor Antagonist
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
N400469266030followed by a unit qualifier and the quantityPackage 00469-2660-30. 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)
VEOZAH ® is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. VEOZAH is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0469-2660
- What is NDC 0469-2660?
- 0469-2660 is the product NDC for Veozah (fezolinetant), Fezolinetant 45 mg/1 tablet, film coated, listed with the FDA by Astellas Pharma US, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Veozah (Fezolinetant).
- What is the active ingredient?
- Fezolinetant.
- 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 Veozah?
- 2 other product NDCs are listed under this name. See all Veozah NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Veozah products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Veozahfezolinetant | Fezolinetant 45 mg/1 | Tablet, Film coatedOral | Astellas Pharma US, Inc. | 0469-2460 | 00469-2460-28 |
| Veozahfezolinetant | Fezolinetant 45 mg/1 | Tablet, Film coatedOral | Astellas Pharma US, Inc. | 0469-2760 | 00469-2760-28 |
Other NDCs under NDA 216578
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 |
|---|---|---|---|---|
| Veozahfezolinetant | Fezolinetant 45 mg/1 | Tablet, Film coatedOral | Astellas Pharma US, Inc. | 0469-2460 |
| Veozahfezolinetant | Fezolinetant 45 mg/1 | Tablet, Film coatedOral | Astellas Pharma US, Inc. | 0469-2760 |