Prescription drug · NDA
Zavzpret (Zavegepant) NDC 63539-135
Zavegepant hydrochloride 10 mg/.1mL · Spray · Nasal · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-135-02 | 6353901350263539013502 | 1 BLISTER PACK in 1 CARTON (63539-135-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (63539-135-01) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 1, 2023 · Sample package |
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)
- Zavzpret
- Generic name (nonproprietary)
- zavegepant
- Active ingredients
- Zavegepant hydrochloride — 10 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- U.S. PharmaceuticalsNDC labeler code 63539
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216386
- Marketing start
- Listing expires
- Other FDA classes
- Calcitonin Gene-related Peptide Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63539-135_3f4a6bba-ce03-463b-9167-65580312987fSPL ID 3f4a6bba-ce03-463b-9167-65580312987fSPL set ID 1191475f-e999-49f4-a805-93ad08596b1bRxCUI 2637974, 2637980UNII 000QCM6HAL
- Pharmacologic class
- Calcitonin Gene-related Peptide 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463539013502followed by a unit qualifier and the quantityPackage 63539-0135-02. 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)
ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 63539-135
- What is NDC 63539-135?
- 63539-135 is the product NDC for Zavzpret (zavegepant), Zavegepant hydrochloride 10 mg/.1mL spray, listed with the FDA by U.S. Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zavzpret (Zavegepant).
- What is the active ingredient?
- Zavegepant hydrochloride.
- Who is the labeler?
- U.S. Pharmaceuticals, NDC labeler code 63539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zavzpret?
- 1 other product NDC are listed under this name. See all Zavzpret NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zavzpret products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zavzpretzavegepant | Zavegepant hydrochloride 10 mg/.1mL | SprayNasal | Pfizer Laboratories Div Pfizer Inc | 0069-3500 | 00069-3500-02 |
Other NDCs under NDA 216386
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 |
|---|---|---|---|---|
| Zavzpretzavegepant | Zavegepant hydrochloride 10 mg/.1mL | SprayNasal | Pfizer Laboratories Div Pfizer Inc | 0069-3500 |