Ciprofloxacin and Dexamethasone

Product NDC: 85766-245
Requested package NDC: 85766-245-75
11-digit product format: 857660245
Labeler code: 85766
Product ID: 85766-245_567b0c1f-2a68-ea09-e063-6394a90a4a9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin and Dexamethasone
Dosage form: SUSPENSION/ DROPS
Route: AURICULAR (OTIC)
Labeler: Sportpharm LLC
Application: ANDA205548
Marketing category: ANDA
Marketing start: 2020-08-10
Substance: CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength: 3; 1 mg/mL; mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
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
A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB		2020-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A205548-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205548-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205548-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205548-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205548-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205548-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205548-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205548-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205548-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205548-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205548-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205548-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205548-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205548-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205548-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205548-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205548-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205548-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205548-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205548-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205548-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205548-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205548-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205548-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205548-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205548-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205548-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205548-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205548-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205548-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205548-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205548-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205548-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205548-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205548-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205548-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205548-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205548-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205548-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205548-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Ciprofloxacin and Dexamethasone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CIPROFLOXACIN HYDROCHLORIDE	3 mg/mL
DEXAMETHASONE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4BA73M5E37	Internal UNII lookup
7S5I7G3JQL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403908	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
780a5554-54ef-4294-b681-8c5300b028b6	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	Sportpharm LLC	780a5554-54ef-4294-b681-8c5300b028b6	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548 ndc (package): 85766-245-75 ndc (product): 85766-245 ndc11 (package): 85766024575
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	Redpharm Drug	546bf602-4b4c-cb08-e063-6394a90a2c55	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	NuCare Pharmaceuticals, Inc.	2f780550-ecbf-98fc-e063-6294a90a11c0	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	NorthStar RxLLC	130deaf4-ced5-abcb-2a01-205c640ddf96	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	Dr. Reddy's Laboratories, Inc.	f07cf7d6-c233-884e-342d-c6c8cd2c8438	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE	86393-32-0	CIPROFLOXACIN HYDROCHLORIDE
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85766-245-75	85766024575	1 BOTTLE, DROPPER in 1 CARTON (85766-245-75) / 7.5 mL in 1 BOTTLE, DROPPER	2026-07-13	No	No	Current