travoprost ophthalmic solution, 0.004%

Generic: travoprost ophthalmic solution, 0.004%

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name travoprost ophthalmic solution, 0.004%
Generic Name travoprost ophthalmic solution, 0.004%
Labeler mylan pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

travoprost .04 mg/mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-9651
Product ID 0378-9651_7a6a2083-70a0-4089-88f0-9ddc088376ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205050
Listing Expiration 2026-12-31
Marketing Start 2019-12-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03789651
Hyphenated Format 0378-9651

Supplemental Identifiers

RxCUI
284008
UPC
0303789651327
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, 0.004% (source: ndc)
Generic Name travoprost ophthalmic solution, 0.004% (source: ndc)
Application Number ANDA205050 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .04 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0378-9651-32) / 2.5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0378-9651-50) / 5 mL in 1 BOTTLE
source: ndc

Packages (2)

0378-9651-32 1 BOTTLE in 1 CARTON (0378-9651-32) / 2.5 mL in 1 BOTTLE 0378-9651-50 1 BOTTLE in 1 CARTON (0378-9651-50) / 5 mL in 1 BOTTLE

Ingredients (1)

travoprost (.04 mg/mL)

Linked Drug Pages (1)

Travoprost Ophthalmic Solution, 0.004% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "7a6a2083-70a0-4089-88f0-9ddc088376ce", "openfda": {"nui": ["N0000175454", "M0017805"], "upc": ["0303789651327"], "unii": ["WJ68R08KX9"], "rxcui": ["284008"], "spl_set_id": ["00dc284f-fd96-423b-bb8f-b90ee13439bf"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0378-9651-32)  / 2.5 mL in 1 BOTTLE", "package_ndc": "0378-9651-32", "marketing_start_date": "20191218"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0378-9651-50)  / 5 mL in 1 BOTTLE", "package_ndc": "0378-9651-50", "marketing_start_date": "20191218"}], "brand_name": "Travoprost Ophthalmic Solution, 0.004%", "product_id": "0378-9651_7a6a2083-70a0-4089-88f0-9ddc088376ce", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Prostaglandin Analog [EPC]", "Prostaglandins [CS]"], "product_ndc": "0378-9651", "generic_name": "Travoprost Ophthalmic Solution, 0.004%", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Travoprost Ophthalmic Solution, 0.004%", "active_ingredients": [{"name": "TRAVOPROST", "strength": ".04 mg/mL"}], "application_number": "ANDA205050", "marketing_category": "ANDA", "marketing_start_date": "20191218", "listing_expiration_date": "20261231"}