Home NDC 47335-507 CEQUA
Product NDC 47335-507
11-digit product format 473350507
Labeler code 47335
Product ID 47335-507_9db609da-42a0-42b1-87f5-020261a871ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyclosporine
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC; TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA210913
Marketing category NDA
Marketing start 2018-08-15
Substance CYCLOSPORINE
Active strength .0009 mg/mL
Pharmacologic classes Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 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 N210913-001 CEQUA CYCLOSPORINE 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210913-001 10441630 2033-08-23 Drug product 2019-11-14 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 N210913-001 11951153 2037-02-28 U-1483 2024-05-02
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 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210913-001 CEQUA 0.09% SOLUTION / OPHTHALMIC RLD, RS 2018-08-14 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 169 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 10441630 2033-08-23 Drug product 2019-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 8980839 2033-08-23 U-1483 Drug product 2018-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 9937225 2033-08-23 U-1483 Drug product 2018-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 10918694 2037-02-28 Drug product 2021-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210913-001 11951153 2037-02-28 U-1483 2024-05-02 5bbf6a4d5a75…
Additional Listing Data#
Finished product Yes
Brand name base CEQUA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOSPORINE .0009 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 83HN0GTJ6D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2055021 Internal RxNorm lookup 2055026 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 47335-507-97 CEQUA 1 in 1 BOX SOLUTION/ DROPS 1 12 47335-507-97 CEQUA 10 in 1 POUCH SOLUTION/ DROPS 10 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-507 CEQUA (CYCLOSPORINE) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20250309_48c3d8a3-4289-4b52-9189-58b48596095c.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 CEQUA CYCLOSPORINE Sun Pharmaceutical Industries, Inc. 48c3d8a3-4289-4b52-9189-58b48596095c 2026-06-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 210913 application number: NDA210913 ndc (product): 47335-507
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47335-507-97 47335050797 1 POUCH in 1 BOX (47335-507-97) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE 1 pouch 2018-08-15 0000-00-00 Yes No Current