Home NDC 70727-529 Rocklatan
Product NDC 70727-529
11-digit product format 707270529
Labeler code 70727
Product ID 70727-529_37be9b45-067b-4ed3-a455-92a4be4b1a25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name netarsudil and latanoprost ophthalmic solution, 0.02%/0.005%
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC; TOPICAL
Labeler Alcon Laboratories, Inc.
Application NDA208259
Marketing category NDA
Marketing start 2019-03-12
Substance LATANOPROST; NETARSUDIL MESYLATE
Active strength .05; .2 mg/mL; mg/mL
Pharmacologic classes Rho Kinase Inhibitor [EPC], Rho Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N208259-001 ROCKLATAN LATANOPROST; NETARSUDIL DIMESYLATE 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12
Orange Book patents# Current patent rows page 1 of 1 · 17 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208259-001 10532993 2026-07-11 U-1524 2020-03-30 N208259-001 10882840 2026-07-11 U-1524 2021-01-22 N208259-001 11021456 2026-07-11 U-1524 2021-06-28 N208259-001 8450344 2026-07-11 U-1524 Drug substance, Drug product 2019-03-28 N208259-001 9096569 2026-07-11 U-1524 Drug substance, Drug product 2019-03-28 N208259-001 10174017 2030-01-27 U-1524 Drug substance, Drug product 2019-03-28 N208259-001 10654844 2030-01-27 U-1524 Drug substance, Drug product 2020-06-10 N208259-001 11028081 2030-01-27 U-1524 2021-06-28 N208259-001 11618748 2030-01-27 U-1524 2023-04-21 N208259-001 8394826 2030-11-10 U-1524 Drug substance, Drug product 2019-03-28 N208259-001 10588901 2034-03-14 U-1524 Drug substance, Drug product 2020-04-15 N208259-001 11020385 2034-03-14 U-1524 2024-07-12 N208259-001 11185538 2034-03-14 Drug product 2021-12-16 N208259-001 11197853 2034-03-14 Drug product 2021-12-16 N208259-001 9415043 2034-03-14 Drug substance 2019-03-28 N208259-001 9931336 2034-03-14 U-1524 Drug substance, Drug product 2019-03-28 N208259-001 9993470 2034-03-14 U-1524 Drug substance, Drug product 2019-03-28
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 · 43 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 2026-09-14 22:38:34 2026-08 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208259-001 ROCKLATAN 0.005%;EQ 0.02% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2019-03-12 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 16 · 631 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N208259-001 10532993 2026-07-11 U-1524 2020-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 10882840 2026-07-11 U-1524 2021-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 11021456 2026-07-11 U-1524 2021-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 8450344 2026-07-11 U-1524 Drug substance, Drug product 2019-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 9096569 2026-07-11 U-1524 Drug substance, Drug product 2019-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 10174017 2030-01-27 U-1524 Drug substance, Drug product 2019-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 10654844 2030-01-27 U-1524 Drug substance, Drug product 2020-06-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 11028081 2030-01-27 U-1524 2021-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 11618748 2030-01-27 U-1524 2023-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 8394826 2030-11-10 U-1524 Drug substance, Drug product 2019-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 10588901 2034-03-14 U-1524 Drug substance, Drug product 2020-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 11020385 2034-03-14 U-1524 2024-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 11185538 2034-03-14 Drug product 2021-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 11197853 2034-03-14 Drug product 2021-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 9415043 2034-03-14 Drug substance 2019-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 9931336 2034-03-14 U-1524 Drug substance, Drug product 2019-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208259-001 9993470 2034-03-14 U-1524 Drug substance, Drug product 2019-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208259-001 10532993 2026-07-11 U-1524 2020-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 10882840 2026-07-11 U-1524 2021-01-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 11021456 2026-07-11 U-1524 2021-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 8450344 2026-07-11 U-1524 Drug substance, Drug product 2019-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 9096569 2026-07-11 U-1524 Drug substance, Drug product 2019-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 10174017 2030-01-27 U-1524 Drug substance, Drug product 2019-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 10654844 2030-01-27 U-1524 Drug substance, Drug product 2020-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 11028081 2030-01-27 U-1524 2021-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 11618748 2030-01-27 U-1524 2023-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 8394826 2030-11-10 U-1524 Drug substance, Drug product 2019-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 10588901 2034-03-14 U-1524 Drug substance, Drug product 2020-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 11020385 2034-03-14 U-1524 2024-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 11185538 2034-03-14 Drug product 2021-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 11197853 2034-03-14 Drug product 2021-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 9415043 2034-03-14 Drug substance 2019-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 9931336 2034-03-14 U-1524 Drug substance, Drug product 2019-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208259-001 9993470 2034-03-14 U-1524 Drug substance, Drug product 2019-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208259-001 10532993 2026-07-11 U-1524 2020-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208259-001 10882840 2026-07-11 U-1524 2021-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208259-001 11021456 2026-07-11 U-1524 2021-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208259-001 8450344 2026-07-11 U-1524 Drug substance, Drug product 2019-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208259-001 9096569 2026-07-11 U-1524 Drug substance, Drug product 2019-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208259-001 10174017 2030-01-27 U-1524 Drug substance, Drug product 2019-03-28 011fe1cb6892…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Rocklatan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NETARSUDIL MESYLATE .2 mg/mL LATANOPROST .05 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VL756B1K0U Internal UNII lookup 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 2119701 Internal RxNorm lookup 2119706 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 70727-529-25 Rocklatan 2.5 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 2.5 14 70727-529-25 Rocklatan 1 in 1 CARTON SOLUTION/ DROPS 1 14 70727-529-99 Rocklatan 1 in 1 CARTON SOLUTION/ DROPS 1 14 70727-529-99 Rocklatan 2.5 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 2.5 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70727-529 ROCKLATAN (NETARSUDIL AND LATANOPROST OPHTHALMIC SOLUTION, 0.02%/0.005%) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 13 Current NDC, Legacy NDC, 4 package rows 20250322_b1d71f41-be06-4a08-94d4-e352198f09c2.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 Rocklatan NETARSUDIL AND LATANOPROST OPHTHALMIC SOLUTION, 0.02%/0.005% Alcon Laboratories, Inc. b1d71f41-be06-4a08-94d4-e352198f09c2 2026-08-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 208259 application number: NDA208259 ndc (product): 70727-529
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 70727-529-25 70727052925 1 BOTTLE, PLASTIC in 1 CARTON (70727-529-25) / 2.5 mL in 1 BOTTLE, PLASTIC 2019-03-12 0000-00-00 No No Current 70727-529-99 70727052999 1 BOTTLE, PLASTIC in 1 CARTON (70727-529-99) / 2.5 mL in 1 BOTTLE, PLASTIC 2019-03-12 0000-00-00 Yes No Current