Prescription drug · NDA
Zurzuvae (Zuranolone) NDC 64406-031
Zuranolone 30 mg/1 · Capsule · Oral · Biogen MA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64406-031-01 | 64406003101 | 1 BOTTLE in 1 CARTON (64406-031-01) / 14 CAPSULE in 1 BOTTLEMarketed from Oct 31, 2023 |
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)
- Zurzuvae
- Generic name (nonproprietary)
- zuranolone
- Active ingredients
- Zuranolone — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Biogen MA Inc.NDC labeler code 64406
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217369
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- GABA A Receptor Positive Modulators (Mechanism)
- Identifiers
- Product ID 64406-031_4473196a-b991-4580-b3d4-dbe24f8fe414SPL ID 4473196a-b991-4580-b3d4-dbe24f8fe414SPL set ID f18e53b0-d0bb-422d-8de7-ab64b7292b29RxCUI 2669910, 2669916, 2669918, 2669920, 2669922, 2669924UNII 7ZW49N180BUPC 0364406031014, 0364406030017, 0364406030024, 0364406029011
- Pharmacologic class
- Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
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
N464406003101followed by a unit qualifier and the quantityPackage 64406-0031-01. 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)
ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 64406-031
- What is NDC 64406-031?
- 64406-031 is the product NDC for Zurzuvae (zuranolone), Zuranolone 30 mg/1 capsule, listed with the FDA by Biogen MA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zurzuvae (Zuranolone).
- What is the active ingredient?
- Zuranolone.
- Who is the labeler?
- Biogen MA Inc., NDC labeler code 64406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zurzuvae?
- 2 other product NDCs are listed under this name. See all Zurzuvae NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zurzuvae products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zurzuvaezuranolone | Zuranolone 20 mg/1 | CapsuleOral | Biogen MA Inc. | 64406-029 | 64406-0029-01 |
| Zurzuvaezuranolone | Zuranolone 25 mg/1 | CapsuleOral | Biogen MA Inc. | 64406-030 | 64406-0030-0164406-0030-02 |
Other NDCs under NDA 217369
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 |
|---|---|---|---|---|
| Zurzuvaezuranolone | Zuranolone 20 mg/1 | CapsuleOral | Biogen MA Inc. | 64406-029 |
| Zurzuvaezuranolone | Zuranolone 25 mg/1 | CapsuleOral | Biogen MA Inc. | 64406-030 |