ciprofloxacin hydrochloride and hydrocortisone

Product NDC: 0781-6218
11-digit product format: 007816218
Labeler code: 0781
Product ID: 0781-6218_c0881bbe-cc95-45d4-9878-3bc8946eff26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciprofloxacin hydrochloride and hydrocortisone
Dosage form: SUSPENSION/ DROPS
Route: AURICULAR (OTIC)
Labeler: Sandoz Inc
Application: NDA020805
Marketing category: NDA AUTHORIZED GENERIC
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: 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
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: ciprofloxacin hydrochloride and hydrocortisone
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
c0881bbe-cc95-45d4-9878-3bc8946eff26	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 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 ndc (product): 0781-6218
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0781-6218-70	00781621870	1 BOTTLE in 1 CARTON (0781-6218-70) / 10 mL in 1 BOTTLE	1 bottle	2026-08-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin Hydrochloride and Hydrocortisone Otic Suspension	Sandoz Inc	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	1