Home NDC 68083-563-01 Latanoprostene Bunod Ophthalmic Solution, 0.024%
Product NDC 68083-563
Requested package NDC 68083-563-01
11-digit product format 680830563
Labeler code 68083
Product ID 68083-563_fac898b8-b3e7-4db5-a3ff-a3ebcdca84cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Latanoprostene Bunod Ophthalmic Solution, 0.024%
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Gland Pharma Limited
Application ANDA217387
Marketing category ANDA
Marketing start 2025-04-29
Substance LATANOPROSTENE BUNOD
Active strength .24 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217387-001 LATANOPROSTENE BUNOD LATANOPROSTENE BUNOD 0.024% SOLUTION/DROPS / OPHTHALMIC AB 2025-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217387-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217387-001 LATANOPROSTENE BUNOD 0.024% SOLUTION/DROPS / OPHTHALMIC AB 2025-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217387-001 LATANOPROSTENE BUNOD 0.024% SOLUTION/DROPS / OPHTHALMIC AB 2025-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217387-001 LATANOPROSTENE BUNOD 0.024% SOLUTION/DROPS / OPHTHALMIC AB 2025-04-29 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217387-001 LATANOPROSTENE BUNOD 0.024% SOLUTION/DROPS / OPHTHALMIC AB 2025-04-29 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217387-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217387-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217387-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217387-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Latanoprostene Bunod Ophthalmic Solution, 0.024%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LATANOPROSTENE BUNOD .24 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I6393O0922 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1988394 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-563-01 Latanoprostene Bunod Ophthalmic Solution, 0.024% 1 in 1 CARTON SOLUTION/ DROPS 1 6 68083-563-01 Latanoprostene Bunod Ophthalmic Solution, 0.024% 2.5 mL in 1 BOTTLE SOLUTION/ DROPS 2.5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-563 LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION, 0.024% SOLUTION/ DROPS [GLAND PHARMA LIMITED] 6 Current NDC, 2 package rows 20250503_1beedfbd-5e2b-4ab1-ab8e-8320e69af1ea.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68083-563-01 68083056301 1 BOTTLE in 1 CARTON (68083-563-01) / 2.5 mL in 1 BOTTLE 1 bottle 2025-04-29 No No Current