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

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 Identifiers#

Field, Values table
Field	Values
Unii	4BA73M5E37
Rxcui	309307

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

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	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	Advanced Rx of Tennessee, LLC	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
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	Direct_Rx	2023-05-18	HUMAN PRESCRIPTION DRUG LABEL	4
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 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

ciprofloxacin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#