ciprofloxacin

Product NDC: 69315-308
11-digit product format: 693150308
Labeler code: 69315
Product ID: 69315-308_8217ec14-6498-4c35-a5a9-511b451b9459
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Leading Pharma, LLC
Application: ANDA077568
Marketing category: ANDA
Marketing start: 2018-11-01
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ciprofloxacin
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
545527e7-05c7-4dbf-ab32-b3fa463d55b0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
a3304bb6-ef4e-06df-d604-35f7e883ed6c	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	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
69315-308-02	ciprofloxacin	1 in 1 CARTON	SOLUTION	1	9
69315-308-02	ciprofloxacin	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION	2.5	9
69315-308-05	ciprofloxacin	5 mL in 1 BOTTLE, PLASTIC	SOLUTION	5	9
69315-308-05	ciprofloxacin	1 in 1 CARTON	SOLUTION	1	9
69315-308-10	ciprofloxacin	10 mL in 1 BOTTLE, PLASTIC	SOLUTION	10	9
69315-308-10	ciprofloxacin	1 in 1 CARTON	SOLUTION	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-308-02	ML - Milliliter	69315-308	29484a41-f092-43ce-a348-e76fd4c3040d	1	2018-12-13
69315-308-05	ML - Milliliter	69315-308	2add2d02-65dc-42a0-a6b9-db42e806c52b	1	2018-12-13
69315-308-10	ML - Milliliter	69315-308	e5526247-6f5b-4f9c-838e-e6b0ab9151d4	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69315-308	CIPROFLOXACIN SOLUTION [LEADING PHARMA, LLC]	9	Current NDC, Legacy NDC, 6 package rows	20240511_545527e7-05c7-4dbf-ab32-b3fa463d55b0.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 ndc (product): 69315-308
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	766251ac-2040-4a79-9ca5-a1e5f1e01cb5	9
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	545527e7-05c7-4dbf-ab32-b3fa463d55b0	9
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	766251ac-2040-4a79-9ca5-a1e5f1e01cb5	9
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	545527e7-05c7-4dbf-ab32-b3fa463d55b0	9
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	545527e7-05c7-4dbf-ab32-b3fa463d55b0	9
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	766251ac-2040-4a79-9ca5-a1e5f1e01cb5	9
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	545527e7-05c7-4dbf-ab32-b3fa463d55b0	9
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	766251ac-2040-4a79-9ca5-a1e5f1e01cb5	9
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	85c48ebc-d94a-4254-86df-d2c1aff09b37	7
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	85c48ebc-d94a-4254-86df-d2c1aff09b37	7
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	85c48ebc-d94a-4254-86df-d2c1aff09b37	7
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	85c48ebc-d94a-4254-86df-d2c1aff09b37	7
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	7def5a45-6725-0521-e053-2991aa0a0bda	6
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	7def5a45-6725-0521-e053-2991aa0a0bda	6
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	7def5a45-6725-0521-e053-2991aa0a0bda	6
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	7def5a45-6725-0521-e053-2991aa0a0bda	6
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	8e5e9dff-19e8-3098-e053-2a95a90aa96a	4
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	7d533171-0879-3854-e053-2a91aa0a3b46	4
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	7d533171-0879-3854-e053-2a91aa0a3b46	4
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	8e5e9dff-19e8-3098-e053-2a95a90aa96a	4
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	8e5e9dff-19e8-3098-e053-2a95a90aa96a	4
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	7d533171-0879-3854-e053-2a91aa0a3b46	4
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	8e5e9dff-19e8-3098-e053-2a95a90aa96a	4
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	7d533171-0879-3854-e053-2a91aa0a3b46	4
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	05b2836d-cd3d-4d7f-970c-66ec2d788667	3
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	190395a8-c05f-4e31-9a89-7af6428ebbb9	3
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	05b2836d-cd3d-4d7f-970c-66ec2d788667	3
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	190395a8-c05f-4e31-9a89-7af6428ebbb9	3
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	05b2836d-cd3d-4d7f-970c-66ec2d788667	3
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	190395a8-c05f-4e31-9a89-7af6428ebbb9	3
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	05b2836d-cd3d-4d7f-970c-66ec2d788667	3
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	190395a8-c05f-4e31-9a89-7af6428ebbb9	3
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	768038be-fe0d-43a9-93bc-15e3ec7b805d	1
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	9af322d9-0753-6159-e053-2a95a90a63df	1
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	9af1178f-baae-4972-e053-2995a90a8222	1
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	30cb2b42-aa4b-8cec-e063-6394a90aa615	1
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	1ebdcd1f-1e64-aea0-e063-6294a90aa4e1	1
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	86c2ba30-9372-4e70-88a2-e6e1da07fa92	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	9af322d9-0753-6159-e053-2a95a90a63df	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	9af1178f-baae-4972-e053-2995a90a8222	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	86c2ba30-9372-4e70-88a2-e6e1da07fa92	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	1ebdcd1f-1e64-aea0-e063-6294a90aa4e1	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	30cb2b42-aa4b-8cec-e063-6394a90aa615	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	768038be-fe0d-43a9-93bc-15e3ec7b805d	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	86c2ba30-9372-4e70-88a2-e6e1da07fa92	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	1ebdcd1f-1e64-aea0-e063-6294a90aa4e1	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	30cb2b42-aa4b-8cec-e063-6394a90aa615	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	9af1178f-baae-4972-e053-2995a90a8222	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	768038be-fe0d-43a9-93bc-15e3ec7b805d	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	9af322d9-0753-6159-e053-2a95a90a63df	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	86c2ba30-9372-4e70-88a2-e6e1da07fa92	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	1ebdcd1f-1e64-aea0-e063-6294a90aa4e1	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	30cb2b42-aa4b-8cec-e063-6394a90aa615	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	9af1178f-baae-4972-e053-2995a90a8222	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	9af322d9-0753-6159-e053-2a95a90a63df	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	768038be-fe0d-43a9-93bc-15e3ec7b805d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69315-308-02	69315030802	1 BOTTLE, PLASTIC in 1 CARTON (69315-308-02) / 2.5 mL in 1 BOTTLE, PLASTIC	2018-11-01	0000-00-00	No	No	Current
69315-308-05	69315030805	1 BOTTLE, PLASTIC in 1 CARTON (69315-308-05) / 5 mL in 1 BOTTLE, PLASTIC	2018-11-01	0000-00-00	No	No	Current
69315-308-10	69315030810	1 BOTTLE, PLASTIC in 1 CARTON (69315-308-10) / 10 mL in 1 BOTTLE, PLASTIC	2018-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin ophthalmic solution USP 0.3% Sterile	HAWAII REPACK, INC	2026-07-12	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin ophthalmic solution USP 0.3% Sterile	Redpharm Drug	2026-06-13	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin ophthalmic solution USP 0.3% Sterile	Sportpharm LLC	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	3
Ciprofloxacin ophthalmic solution USP0.3% Sterile	Preferred Pharmaceuticals, Inc.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	7
Ciprofloxacin ophthalmic solution USP 0.3% Sterile	REMEDYREPACK INC.	2025-07-03	HUMAN PRESCRIPTION DRUG LABEL	9
Ciprofloxacin ophthalmic solution USP 0.3% Sterile	Advanced Rx of Tennessee, LLC	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
Ciprofloxacin ophthalmic solution USP 0.3% Sterile	A-S Medication Solutions	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	9
Ciprofloxacin ophthalmic solution USP 0.3% Sterile	RedPharm Drug	2024-08-02	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	6
Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile	NuCare Pharmaceuticals,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin ophthalmic solution USP 0.3% Sterile	Leading Pharma, LLC \| FDC Limited	2024-05-10	HUMAN PRESCRIPTION DRUG LABEL	9
Ciprofloxacin ophthalmic solution USP0.3% Sterile	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-09-02	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin ophthalmic solution USP0.3% Sterile	A-S Medication Solutions	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	6
CIPROFLOXACIN	Direct_Rx	2023-05-18	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin ophthalmic solution USP0.3% Sterile	REMEDYREPACK INC.	2022-07-11	HUMAN PRESCRIPTION DRUG LABEL	5
Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	3
Ciprofloxacin ophthalmic solution USP0.3% Sterile	A-S Medication Solutions	2021-05-27	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin ophthalmic solution USP0.3% Sterile	RPK Pharmaceuticals, Inc.	2020-12-23	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile	medsource pharmaceuticals \| FDC Limited	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin ophthalmic solution USP 0.3% as base Sterile	medsource pharmaceuticals \| FDC Limited	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	1