CEQUA

Product NDC: 47335-506
11-digit product format: 473350506
Labeler code: 47335
Product ID: 47335-506_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 g/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	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 g/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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48c3d8a3-4289-4b52-9189-58b48596095c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
1be408a0-e15a-4092-b35e-4e294e65196f	Product name	3	20240216
b3fdee3e-0c46-442f-aad5-aa71941d5621	Product name	1	20231023
78fb0708-fce5-decd-6611-5a9fbe3e3dec	Product name	3	20230327
54840517-000d-4fcb-b976-a6ddd102faa0	Product name	1	20220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633a	Product name	1	20181029
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
b1c0d609-8b97-06ee-2cd0-5652a4b1d019	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47335-506-96	CEQUA	10 in 1 POUCH	SOLUTION/ DROPS	10		12
47335-506-96	CEQUA	6 in 1 BOX	SOLUTION/ DROPS	6		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-506-96	EA - Each	47335-506	2ecfcb53-622d-4b17-97c1-48b46e4cecee	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-506	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): 47335-506

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83HN0GTJ6D	CYCLOSPORINE	59865-13-3	CYCLOSPORINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2055026	Cequa 0.09 % Ophthalmic Solution	PSN	48c3d8a3-4289-4b52-9189-58b48596095c	12
2055021	cycloSPORINE 0.09 % Ophthalmic Solution	PSN	48c3d8a3-4289-4b52-9189-58b48596095c	12
2055026	cyclosporine 0.9 MG/ML Ophthalmic Solution [Cequa]	SBD	48c3d8a3-4289-4b52-9189-58b48596095c	12
2055021	cyclosporine 0.9 MG/ML Ophthalmic Solution	SCD	48c3d8a3-4289-4b52-9189-58b48596095c	12
2055026	Cequa 0.09 % Ophthalmic Solution	SY	48c3d8a3-4289-4b52-9189-58b48596095c	12
2055026	Cequa 0.9 MG/ML Ophthalmic Solution	SY	48c3d8a3-4289-4b52-9189-58b48596095c	12
2055021	cyclosporine 0.09 % Ophthalmic Solution	SY	48c3d8a3-4289-4b52-9189-58b48596095c	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-506-96	47335050696	6 POUCH in 1 BOX (47335-506-96) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE	6 pouch	2018-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEQUA	Sun Pharmaceutical Industries, Inc. \| Laboratoire Unither \| TAPI Czech Industries s.r.o.	2026-06-15	HUMAN PRESCRIPTION DRUG LABEL	13