xalatan

Generic: latanoprost

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xalatan
Generic Name latanoprost
Labeler viatris specialty llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

latanoprost 50 ug/mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-419
Product ID 58151-419_45489b8b-2aab-4336-8552-1524493289f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020597
Listing Expiration 2026-12-31
Marketing Start 2024-10-22

Pharmacologic Class

Established (EPC)
prostaglandin analog [epc]
Chemical Structure
prostaglandins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58151419
Hyphenated Format 58151-419

Supplemental Identifiers

RxCUI
314072 542527
UNII
6Z5B6HVF6O
NUI
N0000175454 M0017805

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 xalatan (source: ndc)
Generic Name latanoprost (source: ndc)
Application Number NDA020597 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 50 ug/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (58151-419-35) / 2.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

58151-419-35 1 BOTTLE, DROPPER in 1 CARTON (58151-419-35) / 2.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

latanoprost (50 ug/mL)

Linked Drug Pages (1)

XALATAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "45489b8b-2aab-4336-8552-1524493289f9", "openfda": {"nui": ["N0000175454", "M0017805"], "unii": ["6Z5B6HVF6O"], "rxcui": ["314072", "542527"], "spl_set_id": ["a98595b3-9f47-48e0-b18d-550a2095f264"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (58151-419-35)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "58151-419-35", "marketing_start_date": "20241022"}], "brand_name": "XALATAN", "product_id": "58151-419_45489b8b-2aab-4336-8552-1524493289f9", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "58151-419", "generic_name": "Latanoprost", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XALATAN", "active_ingredients": [{"name": "LATANOPROST", "strength": "50 ug/mL"}], "application_number": "NDA020597", "marketing_category": "NDA", "marketing_start_date": "20241022", "listing_expiration_date": "20261231"}