ZAVZPRET
- Product NDC
- 63539-135
- 11-digit product format
- 635390135
- Labeler code
- 63539
- Product ID
- 63539-135_3f4a6bba-ce03-463b-9167-65580312987f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zavegepant
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA216386
- Marketing category
- NDA
- Marketing start
- 2023-06-01
- Substance
- ZAVEGEPANT HYDROCHLORIDE
- Active strength
- 10 mg/.1mL
- Pharmacologic classes
- Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZAVZPRET
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZAVEGEPANT HYDROCHLORIDE | 10 mg/.1mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 000QCM6HAL |
| Rxcui | 2637974, 2637980 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63539-135-01 | ZAVZPRET | 0.1 mL in 1 VIAL, SINGLE-DOSE | SPRAY | 0.1 | | 4 |
| 63539-135-01 | ZAVZPRET | 1 in 1 BLISTER PACK | SPRAY | 1 | | 4 |
| 63539-135-02 | ZAVZPRET | 1 in 1 CARTON | SPRAY | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-135 | ZAVZPRET (ZAVEGEPANT) SPRAY [U.S. PHARMACEUTICALS] | 3 | Current NDC, 3 package rows | 20250507_1191475f-e999-49f4-a805-93ad08596b1b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63539-135-01 | 63539013501 | 0.1 mL in 1 VIAL, SINGLE-DOSE | 0.1 ml | | | | Historical |
| 63539-135-02 | 63539013502 | 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-DOSE | 1 blister pack | 2023-06-01 | Yes | No | Current |