ciprofloxacin

Product NDC: 50090-4220
11-digit product format: 500904220
Labeler code: 50090
Product ID: 50090-4220_d44b758d-a052-404c-9115-3cc881a0359b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA077568
Marketing category: ANDA
Marketing start: 2018-11-01
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 3 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	50090-4220		D	Discontinued by firm		2026-08-17
excluded package	package	50090-4220	50090-4220-0	D	Discontinued by firm		2026-08-17

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 · 4 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	50090-4220-0	`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	50090-4220-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077568-001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2008-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077568-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077568-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-06-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077568-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077568-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077568-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077568-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077568-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077568-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077568-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077568-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077568-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077568-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077568-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077568-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077568-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077568-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077568-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077568-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077568-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077568-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077568-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077568-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077568-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077568-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077568-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077568-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077568-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077568-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077568-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077568-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077568-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077568-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077568-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077568-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077568-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077568-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077568-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077568-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077568-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077568-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077568-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077568-001	AT	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4220-0	2023-07-07	C162847	48780-1	f386c649-f48e-0266-e053-dadaa90a7c1a	Ciprofloxacin ophthalmic solution USP0.3% Sterile
50090-4220-0	2023-01-30	C162847	48780-1	f386c649-f48e-0266-e053-dadaa90a7c1a	Ciprofloxacin ophthalmic solution USP0.3% Sterile

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4220-0	ML - Milliliter	50090-4220	6604ae6a-465d-4805-ad66-147fc26f35c9	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4220	CIPROFLOXACIN SOLUTION [A-S MEDICATION SOLUTIONS]	6	Legacy NDC	20230708_0230000a-7549-4547-bd73-4dd57fae9c6b.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ciprofloxacin	CIPROFLOXACIN	HAWAII REPACK, INC	4caf49d9-b06f-4d57-aac3-cc64ae12cc95	2026-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Redpharm Drug	541bd97e-b2ff-09a8-e063-6394a90aee96	2026-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Sportpharm LLC	190395a8-c05f-4e31-9a89-7af6428ebbb9	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Preferred Pharmaceuticals, Inc.	85c48ebc-d94a-4254-86df-d2c1aff09b37	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Advanced Rx of Tennessee, LLC	30cb2b42-aa4b-8cec-e063-6394a90aa615	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	A-S Medication Solutions	766251ac-2040-4a79-9ca5-a1e5f1e01cb5	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	7def5a45-6725-0521-e053-2991aa0a0bda	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	7d533171-0879-3854-e053-2a91aa0a3b46	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Leading Pharma, LLC	545527e7-05c7-4dbf-ab32-b3fa463d55b0	2024-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Asclemed USA, Inc.	86c2ba30-9372-4e70-88a2-e6e1da07fa92	2023-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568
ciprofloxacin	CIPROFLOXACIN	Proficient Rx LP	05b2836d-cd3d-4d7f-970c-66ec2d788667	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077568 application number: ANDA077568

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE	86393-32-0	CIPROFLOXACIN HYDROCHLORIDE
5E8K9I0O4U	CIPROFLOXACIN	85721-33-1	Ciprofloxacin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4220-0	50090422000	1 BOTTLE, PLASTIC in 1 CARTON (50090-4220-0) > 2.5 mL in 1 BOTTLE, PLASTIC	2019-03-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin ophthalmic solution USP0.3% Sterile	A-S Medication Solutions	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	6