CIPRODEX

Product NDC: 21695-969
11-digit product format: 216950969
Labeler code: 21695
Product ID: 21695-969_895c2307-aeeb-49fd-ac3d-750a463fc3ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciprofloxacin and dexamethasone
Dosage form: SUSPENSION
Route: AURICULAR (OTIC)
Labeler: Rebel Distributors Corp
Application: NDA021537
Marketing category: NDA
Marketing start: 2003-08-15
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength: 3 mg/mL; mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-969		I	Inactivated by FDA		2026-10-05
excluded package	package	21695-969	21695-969-75	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-969-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-969-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-969-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-969-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-969-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-969-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-969-75	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-969-75	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-969-75	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-969-75	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-969-75	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-969-75	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-969-75	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-969-75	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-969-75	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-969-75	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-969-75	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-969-75	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-969-75	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-969-75	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-969-75	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-969-75	`110d247fa046…`	`a55b01930146…`

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
N021537-001	CIPRODEX	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021537-001	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.

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	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC		RLD, RS	2003-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC		RLD, RS	2003-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC		RLD, RS	2003-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC		RLD, RS	2003-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`f41ea6bd6efb…`

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	N021537-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021537-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021537-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021537-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021537-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021537-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021537-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021537-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021537-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021537-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021537-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021537-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021537-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021537-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021537-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021537-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021537-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021537-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021537-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021537-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021537-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021537-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021537-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021537-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021537-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021537-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021537-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021537-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021537-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021537-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021537-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021537-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021537-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021537-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021537-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021537-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021537-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021537-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021537-001	6284804	2020-08-10				`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	6359016	2020-08-10				`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
90aab9f8-63f3-478d-8db8-951525a18ab1	Product name	1	20180814
200e1d3d-46da-4371-beed-747da3cb3ff8	Product name	1	20180702
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
9e453f34-aacb-44d5-a119-c0e3dc1fca2a	Product name	1	20160622
01eecbfe-0b50-413b-8898-6905c89b6568	Product name	1	20151228
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
a3304bb6-ef4e-06df-d604-35f7e883ed6c	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
de5ea793-ffd9-0308-b0ca-00d9967be4ee	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-969-75	2019-09-24	C162847	48780-1	934fe258-4d40-48b1-e053-8cdaa90a720a	CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-969-75	CIPRODEX	7.5 mL in 1 BOTTLE, PLASTIC	SUSPENSION	7.5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-969-75	ML - Milliliter	21695-969	e089ffc0-1c8c-42cf-95c1-18dc5513a133	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CIPROFLOXACIN HYDROCHLORIDE	ACTIVE INGREDIENT	4BA73M5E37	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
CIPROFLOXACIN	ACTIVE MOIETY	5E8K9I0O4U	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-969	CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20111021_895c2307-aeeb-49fd-ac3d-750a463fc3ef.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
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	Sandoz Inc	89fef4d2-7078-47f1-96bf-aca50b135a97	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021537 application number: NDA021537

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
404630	CIPRODEX 0.3 % / 0.1 % Otic Suspension	PSN	895c2307-aeeb-49fd-ac3d-750a463fc3ef	1
403908	ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic Suspension	PSN	895c2307-aeeb-49fd-ac3d-750a463fc3ef	1
404630	ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension [Ciprodex]	SBD	895c2307-aeeb-49fd-ac3d-750a463fc3ef	1
403908	ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension	SCD	895c2307-aeeb-49fd-ac3d-750a463fc3ef	1
404630	Ciprodex (ciprofloxacin (as ciprofloxacin HCl) 3 MG/ML / dexamethasone 1 MG/ML) Otic Suspension	SY	895c2307-aeeb-49fd-ac3d-750a463fc3ef	1
404630	Ciprodex (ciprofloxacin 0.3 % / dexamethasone 0.1 % ) Otic Suspension	SY	895c2307-aeeb-49fd-ac3d-750a463fc3ef	1
403908	ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension	SY	895c2307-aeeb-49fd-ac3d-750a463fc3ef	1
403908	ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic Suspension	SY	895c2307-aeeb-49fd-ac3d-750a463fc3ef	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-969-75	21695096975	7.5 mL in 1 BOTTLE, PLASTIC	7.5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension	Rebel Distributors Corp	2011-08-23	HUMAN PRESCRIPTION DRUG LABEL	1