zavzpret

Generic: zavegepant

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zavzpret
Generic Name zavegepant
Labeler u.s. pharmaceuticals
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

zavegepant hydrochloride 10 mg/.1mL

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-135
Product ID 63539-135_3f4a6bba-ce03-463b-9167-65580312987f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216386
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

Pharmacologic Class

Classes
calcitonin gene-related peptide receptor antagonist [epc] calcitonin gene-related peptide receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539135
Hyphenated Format 63539-135

Supplemental Identifiers

RxCUI
2637974 2637980
UNII
000QCM6HAL

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zavzpret (source: ndc)
Generic Name zavegepant (source: ndc)
Application Number NDA216386 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/.1mL
source: ndc
Packaging
  • 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
source: ndc

Packages (1)

63539-135-02 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

Ingredients (1)

zavegepant hydrochloride (10 mg/.1mL)

Linked Drug Pages (1)

ZAVZPRET ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "3f4a6bba-ce03-463b-9167-65580312987f", "openfda": {"unii": ["000QCM6HAL"], "rxcui": ["2637974", "2637980"], "spl_set_id": ["1191475f-e999-49f4-a805-93ad08596b1b"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "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", "package_ndc": "63539-135-02", "marketing_start_date": "20230601"}], "brand_name": "ZAVZPRET", "product_id": "63539-135_3f4a6bba-ce03-463b-9167-65580312987f", "dosage_form": "SPRAY", "pharm_class": ["Calcitonin Gene-related Peptide Receptor Antagonist [EPC]", "Calcitonin Gene-related Peptide Receptor Antagonists [MoA]"], "product_ndc": "63539-135", "generic_name": "zavegepant", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZAVZPRET", "active_ingredients": [{"name": "ZAVEGEPANT HYDROCHLORIDE", "strength": "10 mg/.1mL"}], "application_number": "NDA216386", "marketing_category": "NDA", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}