CIPRO

Product NDC: 50090-6043
11-digit product format: 500906043
Labeler code: 50090
Product ID: 50090-6043_cad2cea9-68bf-4e4e-afc6-60bd21846b6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciprofloxacin hydrochloride and hydrocortisone
Dosage form: SUSPENSION/ DROPS
Route: AURICULAR (OTIC)
Labeler: A-S Medication Solutions
Application: NDA020805
Marketing category: NDA
Marketing start: 1999-03-15
Substance: CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
Active strength: 2; 10 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: 2026-12-31
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
N020805-001	CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020805-001	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	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`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	N020805-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020805-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020805-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020805-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020805-001	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: CIPRO
Brand name suffix: HC
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CIPROFLOXACIN HYDROCHLORIDE	2 mg/mL
HYDROCORTISONE	10 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
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
213320	Internal RxNorm lookup
309305	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
ab640d62-f470-4b50-818f-0c0a33904743	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
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
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
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
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a3304bb6-ef4e-06df-d604-35f7e883ed6c	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
de5ea793-ffd9-0308-b0ca-00d9967be4ee	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6043-0	CIPROHC	10 mL in 1 BOTTLE	SUSPENSION/ DROPS	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6043-0	ML - Milliliter	50090-6043	f4a2ea43-f08c-447d-85f7-2d2acd449b22	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6043	CIPRO HC (CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE) SUSPENSION/ DROPS [A-S MEDICATION SOLUTIONS]	3	Current NDC, Legacy NDC, 1 package rows	20231122_ab640d62-f470-4b50-818f-0c0a33904743.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ciprofloxacin hydrochloride and hydrocortisone	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	Sandoz Inc	c0881bbe-cc95-45d4-9878-3bc8946eff26	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	A-S Medication Solutions	d2c40b07-dc39-46c6-8ea1-b288589a46d1	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	Sandoz Inc	b26594a3-2adf-4954-8be0-5bd6f8de9671	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	A-S Medication Solutions	ab640d62-f470-4b50-818f-0c0a33904743	2023-11-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805 ndc (product): 50090-6043
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	Asclemed USA, Inc.	eafad445-2735-434b-a1c6-e1c6b201d2cf	2022-09-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE	86393-32-0	CIPROFLOXACIN HYDROCHLORIDE
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
213320	Cipro HC 0.2 % / 1 % Otic Suspension	PSN	ab640d62-f470-4b50-818f-0c0a33904743	3
309305	ciprofloxacin 0.2 % / hydrocortisone 1 % Otic Suspension	PSN	ab640d62-f470-4b50-818f-0c0a33904743	3
213320	ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic Suspension [Cipro HC]	SBD	ab640d62-f470-4b50-818f-0c0a33904743	3
309305	ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic Suspension	SCD	ab640d62-f470-4b50-818f-0c0a33904743	3
213320	Cipro HC (ciprofloxacin 0.2 % / hydrocortisone 1 % ) Otic Suspension	SY	ab640d62-f470-4b50-818f-0c0a33904743	3
213320	Cipro HC 2/10 Otic Suspension	SY	ab640d62-f470-4b50-818f-0c0a33904743	3
309305	ciprofloxacin 0.2 % / hydrocortisone 1 % Otic Suspension	SY	ab640d62-f470-4b50-818f-0c0a33904743	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6043-0	50090604300	10 mL in 1 BOTTLE (50090-6043-0)	10 ml	2022-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CIPRO ® HC OTIC (ciprofloxacin hydrochloride and hydrocortisone otic suspension)	A-S Medication Solutions	2023-11-21	HUMAN PRESCRIPTION DRUG LABEL	3