latanoprostene bunod ophthalmic solution, 0.024%

Generic: latanoprostene bunod ophthalmic solution, 0.024%

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name latanoprostene bunod ophthalmic solution, 0.024%
Generic Name latanoprostene bunod ophthalmic solution, 0.024%
Labeler gland pharma limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

latanoprostene bunod .24 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-564
Product ID 68083-564_fac898b8-b3e7-4db5-a3ff-a3ebcdca84cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217387
Listing Expiration 2026-12-31
Marketing Start 2025-04-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083564
Hyphenated Format 68083-564

Supplemental Identifiers

RxCUI
1988394
UNII
I6393O0922

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 latanoprostene bunod ophthalmic solution, 0.024% (source: ndc)
Generic Name latanoprostene bunod ophthalmic solution, 0.024% (source: ndc)
Application Number ANDA217387 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .24 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68083-564-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

68083-564-01 1 BOTTLE in 1 CARTON (68083-564-01) / 5 mL in 1 BOTTLE

Ingredients (1)

latanoprostene bunod (.24 mg/mL)

Linked Drug Pages (1)

Latanoprostene Bunod Ophthalmic Solution, 0.024% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "fac898b8-b3e7-4db5-a3ff-a3ebcdca84cf", "openfda": {"unii": ["I6393O0922"], "rxcui": ["1988394"], "spl_set_id": ["1beedfbd-5e2b-4ab1-ab8e-8320e69af1ea"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68083-564-01)  / 5 mL in 1 BOTTLE", "package_ndc": "68083-564-01", "marketing_start_date": "20250429"}], "brand_name": "Latanoprostene Bunod Ophthalmic Solution, 0.024%", "product_id": "68083-564_fac898b8-b3e7-4db5-a3ff-a3ebcdca84cf", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "68083-564", "generic_name": "Latanoprostene Bunod Ophthalmic Solution, 0.024%", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Latanoprostene Bunod Ophthalmic Solution, 0.024%", "active_ingredients": [{"name": "LATANOPROSTENE BUNOD", "strength": ".24 mg/mL"}], "application_number": "ANDA217387", "marketing_category": "ANDA", "marketing_start_date": "20250429", "listing_expiration_date": "20261231"}