CIPROFLOXACIN HYDROCHLORIDE

Product NDC: 72888-102
11-digit product format: 728880102
Labeler code: 72888
Product ID: 72888-102_30142b39-1441-7d9f-e063-6394a90ac169
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CIPROFLOXACIN HYDROCHLORIDE
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Advagen Pharma Limited
Application: ANDA075928
Marketing category: ANDA
Marketing start: 2022-03-16
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 3 mg/mL
Pharmacologic classes: 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
A075928-001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2004-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075928-001	AT

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`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	A075928-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075928-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075928-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075928-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075928-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075928-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075928-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075928-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075928-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075928-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075928-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075928-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075928-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075928-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075928-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075928-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075928-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075928-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075928-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075928-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075928-001	AT	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075928-001	AT	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
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309307	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
74af98f1-eb6d-473b-94a9-67920dba8c3d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
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
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
de5ea793-ffd9-0308-b0ca-00d9967be4ee	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72888-102-21	CIPROFLOXACIN HYDROCHLORIDE	2.5 mL in 1 BOTTLE	SOLUTION	2.5	2
72888-102-22	CIPROFLOXACIN HYDROCHLORIDE	5 mL in 1 BOTTLE	SOLUTION	5	2
72888-102-23	CIPROFLOXACIN HYDROCHLORIDE	10 mL in 1 BOTTLE	SOLUTION	10	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72888-102-21	ML - Milliliter	72888-102	ae19fece-d5e3-40f4-b673-dd997e45e740	1	2025-05-14
72888-102-22	ML - Milliliter	72888-102	96b414c4-1624-4506-9175-785301bd2174	1	2025-05-14
72888-102-23	ML - Milliliter	72888-102	90d05274-a2f4-47c4-ad42-627a97848abc	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72888-102	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [ADVAGEN PHARMA LIMITED]	2	Current NDC, 3 package rows	20250313_74af98f1-eb6d-473b-94a9-67920dba8c3d.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 HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	Advagen Pharma Limited	74af98f1-eb6d-473b-94a9-67920dba8c3d	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075928 application number: ANDA075928 ndc (product): 72888-102

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE	86393-32-0	CIPROFLOXACIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	74af98f1-eb6d-473b-94a9-67920dba8c3d	2
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	74af98f1-eb6d-473b-94a9-67920dba8c3d	2
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	74af98f1-eb6d-473b-94a9-67920dba8c3d	2
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	74af98f1-eb6d-473b-94a9-67920dba8c3d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72888-102-21	72888010221	2.5 mL in 1 BOTTLE (72888-102-21)	2.5 ml	2022-03-16	No	No	Current
72888-102-22	72888010222	5 mL in 1 BOTTLE (72888-102-22)	5 ml	2022-03-16	No	No	Current
72888-102-23	72888010223	10 mL in 1 BOTTLE (72888-102-23)	10 ml	2022-03-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin Ophthalmic Solution, USP 0.3% Sterile	Advagen Pharma Limited	2025-03-11	HUMAN PRESCRIPTION DRUG LABEL	2