Home NDC 58151-419 XALATAN
Product NDC 58151-419
11-digit product format 581510419
Labeler code 58151
Product ID 58151-419_45489b8b-2aab-4336-8552-1524493289f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Latanoprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Viatris Specialty LLC
Application NDA020597
Marketing category NDA
Marketing start 2024-10-22
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 N020597-001 XALATAN LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020597-001 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.
Product history page 1 of 2 · 42 observed 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 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020597-001 XALATAN 0.005% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1996-06-05 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base XALATAN
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314072 Internal RxNorm lookup 542527 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 58151-419-35 XALATAN 1 in 1 CARTON SOLUTION/ DROPS 1 2 58151-419-35 XALATAN 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-419 XALATAN (LATANOPROST) SOLUTION/ DROPS [VIATRIS SPECIALTY LLC] 2 Current NDC, 2 package rows 20241025_a98595b3-9f47-48e0-b18d-550a2095f264.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 58151-419-35 58151041935 1 BOTTLE, DROPPER in 1 CARTON (58151-419-35) / 2.5 mL in 1 BOTTLE, DROPPER 2024-10-22 No No Current