Home NDC 68083-609 latanoprost
Product NDC 68083-609
11-digit product format 680830609
Labeler code 68083
Product ID 68083-609_c63757a2-c757-4098-a29d-7a94104d050f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name latanoprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Gland Pharma Limited
Application ANDA218257
Marketing category ANDA
Marketing start 2024-11-26
Substance LATANOPROST
Active strength 50 ug/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 42 .
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 A218257-001 LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218257-001 AT
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 2026-08-18 06:07:40 2026-07 A218257-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218257-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218257-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218257-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218257-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218257-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218257-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218257-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218257-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2024-11-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base latanoprost
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LATANOPROST 50 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6Z5B6HVF6O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314072 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 68083-609-01 latanoprost 1 in 1 CARTON SOLUTION/ DROPS 1 5 68083-609-01 latanoprost 2.5 mL in 1 BOTTLE SOLUTION/ DROPS 2.5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-609 LATANOPROST SOLUTION/ DROPS [GLAND PHARMA LIMITED] 5 Current NDC, 2 package rows 20241205_113abcc6-6e5c-4a57-ad6a-d69508ee990e.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 · 3 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 68083-609-01 68083060901 1 BOTTLE in 1 CARTON (68083-609-01) / 2.5 mL in 1 BOTTLE 1 bottle 2024-11-26 No No Current