Tyrvaya

Orange BookUNIISPLATC N07BA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOyster Point Pharma, Inc.

CountryUS (United States)

ATC codeN07BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7352103002
2 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMP
ndc11
7352103090
1 BOTTLE, PUMP in 1 CARTON (73521-030-90) / 4.2 mL in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)

82269ASB48

VARENICLINE TARTRATE

RxCUI 636674

Orange Book

N213978

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "82269ASB48",
    "rxcui": "636674",
    "inchikey": "TWYFGYXQSYOKLK-CYUSMAIQSA-N",
    "display_name": "VARENICLINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "014c93dc-5737-479c-a9f0-aaadac1ac298": {
      "match": "brand_token",
      "title": "TYRVAYA (VARENICLINE) SPRAY [OYSTER POINT PHARMA, INC.]",
      "spl_version": "14",
      "published_date": "2025-03-11"
    }
  },
  "productid": "73521-030_b8c6f558-9cbd-4389-a8d7-a8c698c49093",
  "productndc": "73521-030",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "213978",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.03MG BASE/SPRAY",
        "product_no": "001",
        "approval_date": "Oct 15, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VARENICLINE TARTRATE",
  "proprietary_name": "Tyrvaya",
  "active_ingred_unit": "mg/.05mL",
  "application_number": "NDA213978",
  "marketing_category": "NDA",
  "nonproprietary_name": "varenicline",
  "start_marketing_date": "20211020",
  "active_numerator_strength": ".03"
}

Related drugs

Other records sharing ATC code N07BA03.

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