Home NDC 47335-317 XELPROS
Product NDC 47335-317
11-digit product format 473350317
Labeler code 47335
Product ID 47335-317_44b8ddc0-81dc-4613-bbe8-0da960cc179c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name latanoprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC; TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA206185
Marketing category NDA
Marketing start 2018-09-12
Substance LATANOPROST
Active strength .05 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 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 N206185-001 XELPROS LATANOPROST 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206185-001 9539262 2028-10-15 U-2400 2018-09-25 N206185-001 9629852 2029-09-12 Drug product 2018-09-25
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 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD 2018-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206185-001 XELPROS 0.005% EMULSION / OPHTHALMIC RLD, RS 2018-09-12 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206185-001 9539262 2028-10-15 U-2400 2018-09-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206185-001 9629852 2029-09-12 Drug product 2018-09-25 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base XELPROS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LATANOPROST .05 mg/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 2056743 Internal RxNorm lookup 2056748 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-317 XELPROS (LATANOPROST) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 Current NDC, Legacy NDC, 8 package rows 20241222_34ad5cf6-4df0-4104-bddd-4c7631133ded.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XELPROS LATANOPROST Sun Pharmaceutical Industries, Inc. 34ad5cf6-4df0-4104-bddd-4c7631133ded 2025-12-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 206185 application number: NDA206185 ndc (product): 47335-317
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 47335-317-90 47335031790 1 BOTTLE, DROPPER in 1 BOX (47335-317-90) / 2.5 mL in 1 BOTTLE, DROPPER 2018-09-12 0000-00-00 No No Current 47335-317-92 47335031792 3 BOTTLE, DROPPER in 1 BOX (47335-317-92) / 2.5 mL in 1 BOTTLE, DROPPER 2018-09-12 0000-00-00 No No Current 47335-317-94 47335031794 3 BOTTLE, DROPPER in 1 BOX (47335-317-94) / 2.5 mL in 1 BOTTLE, DROPPER 2018-09-12 0000-00-00 Yes No Current 47335-317-98 47335031798 1 BOTTLE, DROPPER in 1 BOX (47335-317-98) / 2.5 mL in 1 BOTTLE, DROPPER 2018-09-12 0000-00-00 Yes No Current