Home NDC 55545-1010 LATANOPROST
Product NDC 55545-1010
11-digit product format 555451010
Labeler code 55545
Product ID 55545-1010_987a5fd5-0afd-1d4e-e053-2a95a90a5d1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name latanoprost
Dosage form SOLUTION
Route OPHTHALMIC
Labeler FDC Limited
Application ANDA202442
Marketing category ANDA
Marketing start 2016-09-01
Marketing end 0000-00-00
Substance LATANOPROST
Active strength 50 ug/mL
Pharmacologic classes Prostaglandin Analog [EPC],Prostaglandins [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 A202442-001 LATANOPROST LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202442-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202442-001 LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC AT 2016-04-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55545-1010-1 LATANOPROST 1 in 1 CARTON SOLUTION 1 2 55545-1010-1 LATANOPROST 2.5 mL in 1 BOTTLE, DROPPER SOLUTION 2.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55545-1010 LATANOPROST SOLUTION [FDC LIMITED] 2 Legacy NDC, 2 package rows 20191130_891a5db6-ca9b-48f0-b3c6-7cd56e310c5a.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 Status 55545-1010-1 55545101001 1 in 1 CARTON Historical