travoprost ophthalmic solution (68083-602)

Drug Facts

Product Profile

Brand Name travoprost ophthalmic solution

Generic Name travoprost ophthalmic solution

Labeler gland pharma limited

Dosage Form SOLUTION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

travoprost .04 mg/mL

Manufacturer

Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-602

Product ID 68083-602_7c35e414-614e-4d70-96ff-3adae7238166

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA218159

Listing Expiration 2026-12-31

Marketing Start 2024-07-12

Pharmacologic Class

Established (EPC)

prostaglandin analog [epc]

Chemical Structure

prostaglandins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083602

Hyphenated Format 68083-602

Supplemental Identifiers

RxCUI

284008

UNII

WJ68R08KX9

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 travoprost ophthalmic solution (source: ndc)

Generic Name travoprost ophthalmic solution (source: ndc)

Application Number ANDA218159 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

.04 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (68083-602-01) / 5 mL in 1 BOTTLE

source: ndc

Packages (1)

68083-602-01 1 BOTTLE in 1 CARTON (68083-602-01) / 5 mL in 1 BOTTLE

Ingredients (1)

travoprost (.04 mg/mL)

Linked Drug Pages (1)

Travoprost Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "7c35e414-614e-4d70-96ff-3adae7238166", "openfda": {"nui": ["N0000175454", "M0017805"], "unii": ["WJ68R08KX9"], "rxcui": ["284008"], "spl_set_id": ["71c9ea95-f577-411a-8e22-819e44d9680e"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68083-602-01)  / 5 mL in 1 BOTTLE", "package_ndc": "68083-602-01", "marketing_start_date": "20240712"}], "brand_name": "Travoprost Ophthalmic Solution", "product_id": "68083-602_7c35e414-614e-4d70-96ff-3adae7238166", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Prostaglandin Analog [EPC]", "Prostaglandins [CS]"], "product_ndc": "68083-602", "generic_name": "Travoprost Ophthalmic Solution", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Travoprost Ophthalmic Solution", "active_ingredients": [{"name": "TRAVOPROST", "strength": ".04 mg/mL"}], "application_number": "ANDA218159", "marketing_category": "ANDA", "marketing_start_date": "20240712", "listing_expiration_date": "20261231"}