tyrvaya

Generic: varenicline

Labeler: oyster point pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tyrvaya
Generic Name varenicline
Labeler oyster point pharma, inc.
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

varenicline tartrate .03 mg/.05mL

Manufacturer
Oyster Point Pharma, Inc.

Identifiers & Regulatory

Product NDC 73521-030
Product ID 73521-030_b8c6f558-9cbd-4389-a8d7-a8c698c49093
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213978
Listing Expiration 2026-12-31
Marketing Start 2021-10-20

Pharmacologic Class

Classes
cholinergic agonists [moa] cholinergic receptor agonist [epc] partial cholinergic nicotinic agonist [epc] partial cholinergic nicotinic agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73521030
Hyphenated Format 73521-030

Supplemental Identifiers

RxCUI
2572365 2572371
UNII
82269ASB48

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 tyrvaya (source: ndc)
Generic Name varenicline (source: ndc)
Application Number NDA213978 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • .03 mg/.05mL
source: ndc
Packaging
  • 2 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (73521-030-90) / 4.2 mL in 1 BOTTLE, PUMP
source: ndc

Packages (2)

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

Ingredients (1)

varenicline tartrate (.03 mg/.05mL)

Linked Drug Pages (1)

Tyrvaya ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "b8c6f558-9cbd-4389-a8d7-a8c698c49093", "openfda": {"unii": ["82269ASB48"], "rxcui": ["2572365", "2572371"], "spl_set_id": ["014c93dc-5737-479c-a9f0-aaadac1ac298"], "manufacturer_name": ["Oyster Point Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PUMP in 1 CARTON (73521-030-02)  / 4.2 mL in 1 BOTTLE, PUMP", "package_ndc": "73521-030-02", "marketing_start_date": "20211020"}, {"sample": true, "description": "1 BOTTLE, PUMP in 1 CARTON (73521-030-90)  / 4.2 mL in 1 BOTTLE, PUMP", "package_ndc": "73521-030-90", "marketing_start_date": "20211020"}], "brand_name": "Tyrvaya", "product_id": "73521-030_b8c6f558-9cbd-4389-a8d7-a8c698c49093", "dosage_form": "SPRAY", "pharm_class": ["Cholinergic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]", "Partial Cholinergic Nicotinic Agonist [EPC]", "Partial Cholinergic Nicotinic Agonists [MoA]"], "product_ndc": "73521-030", "generic_name": "varenicline", "labeler_name": "Oyster Point Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tyrvaya", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": ".03 mg/.05mL"}], "application_number": "NDA213978", "marketing_category": "NDA", "marketing_start_date": "20211020", "listing_expiration_date": "20261231"}