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United States · US · US:0069-3500_d6d7cbe0-0760-4b2b-8323-5b6882832a60

ZAVZPRET

Orange BookUNIISPLATC N02CD08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeN02CD08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0069350002
    6 BLISTER PACK in 1 CARTON (0069-3500-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0069-3500-01) / .1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
000QCM6HAL
ZAVEGEPANT HYDROCHLORIDE
Orange Book
N216386
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "000QCM6HAL",
    "rxcui": null,
    "inchikey": "VQDUWCSSPSOSNA-RYWNGCACSA-N",
    "display_name": "ZAVEGEPANT HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "1191475f-e999-49f4-a805-93ad08596b1b": {
      "match": "brand_token",
      "title": "ZAVZPRET (ZAVEGEPANT) SPRAY [U.S. PHARMACEUTICALS]",
      "spl_version": "4",
      "published_date": "2025-12-31"
    }
  },
  "productid": "0069-3500_d6d7cbe0-0760-4b2b-8323-5b6882832a60",
  "productndc": "0069-3500",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "216386",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE/SPRAY",
        "product_no": "001",
        "approval_date": "Mar 9, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZAVEGEPANT HYDROCHLORIDE",
  "proprietary_name": "ZAVZPRET",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA216386",
  "marketing_category": "NDA",
  "nonproprietary_name": "zavegepant",
  "start_marketing_date": "20230601",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N02CD08.

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