Ciprofloxacin Hydrochloride

Product NDC: 61314-656
11-digit product format: 613140656
Labeler code: 61314
Product ID: 61314-656_1c86f423-a99a-4e4d-9502-42799a9d40e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ciprofloxacin Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: NDA019992
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2004-05-07
Substance: CIPROFLOXACIN HYDROCHLORIDE
Active strength: 3 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC], Quinolones [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 1.

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
N019992-001	CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019992-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019992-001	CILOXAN	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1990-12-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019992-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019992-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019992-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019992-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019992-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019992-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019992-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019992-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019992-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019992-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019992-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019992-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019992-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019992-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019992-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019992-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019992-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019992-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019992-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019992-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019992-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019992-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019992-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019992-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019992-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019992-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019992-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019992-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019992-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019992-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019992-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019992-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019992-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019992-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019992-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019992-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019992-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019992-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019992-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019992-001	AT	1	`cb3db0bc1861…`

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
ab52b14d-345b-47ff-a832-465caddd3801	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
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
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
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
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
61314-656-05	Ciprofloxacin Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	6
61314-656-05	Ciprofloxacin Hydrochloride	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5	6
61314-656-10	Ciprofloxacin Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	6
61314-656-10	Ciprofloxacin Hydrochloride	10 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	10	6
61314-656-25	Ciprofloxacin Hydrochloride	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	2.5	6
61314-656-25	Ciprofloxacin Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-656-05	ML - Milliliter	61314-656	85c76317-eba1-4f81-b0d2-887f901b07b8	1	2012-07-24
61314-656-10	ML - Milliliter	61314-656	8375b475-200a-48ff-bf99-098a651a8dbc	1	2012-07-24
61314-656-25	ML - Milliliter	61314-656	71aaf077-ded6-48b2-a3b0-921dfa274c0f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CIPROFLOXACIN HYDROCHLORIDE	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
CIPROFLOXACIN	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	2
CIPROFLOXACIN HYDROCHLORIDE	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1
ciprofloxacin hydrochloride	ACTIVE INGREDIENT	4BA73M5E37	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]	1
ciprofloxacin	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]	1
CIPROFLOXACIN	ACTIVE MOIETY	5E8K9I0O4U	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1
acetic acid	INACTIVE INGREDIENT	Q40Q9N063P	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1
sodium acetate	INACTIVE INGREDIENT	4550K0SC9B	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-656	CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]	6	Current NDC, Legacy NDC, 6 package rows	20220702_ab52b14d-345b-47ff-a832-465caddd3801.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 Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Redpharm Drug	1ac4540c-d0f7-70bc-e063-6394a90a0f7a	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	78641acd-eedf-4b68-bb18-da0874415f59	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	a2cec2cc-729b-4baa-8df1-c3f70847a483	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Asclemed USA, Inc.	509b932e-9229-42c0-8a4c-f3257ffdca49	2025-03-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5cf0f572-48fc-6a3a-e053-2991aa0a8437	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6301febb-01aa-1af5-e053-2991aa0aa309	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	ec3a3dcf-b9c9-432e-adfe-4b30cade8931	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	694b79f6-599f-4a71-bf02-d0d09767a735	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	54c73290-bd89-3453-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	e04dfddd-6177-4c2e-8f42-acd65848e6e2	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Sandoz Inc	ab52b14d-345b-47ff-a832-465caddd3801	2019-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019992 application number: NDA019992 ndc (product): 61314-656

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	694b79f6-599f-4a71-bf02-d0d09767a735	13
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	694b79f6-599f-4a71-bf02-d0d09767a735	13
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	694b79f6-599f-4a71-bf02-d0d09767a735	13
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	694b79f6-599f-4a71-bf02-d0d09767a735	13
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	0fa41584-2f85-4ed9-9042-a713cd7ecc59	12
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	0fa41584-2f85-4ed9-9042-a713cd7ecc59	12
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	0fa41584-2f85-4ed9-9042-a713cd7ecc59	12
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	0fa41584-2f85-4ed9-9042-a713cd7ecc59	12
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	a2cec2cc-729b-4baa-8df1-c3f70847a483	10
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	a2cec2cc-729b-4baa-8df1-c3f70847a483	10
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	a2cec2cc-729b-4baa-8df1-c3f70847a483	10
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	a2cec2cc-729b-4baa-8df1-c3f70847a483	10
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	ec3a3dcf-b9c9-432e-adfe-4b30cade8931	9
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	ec3a3dcf-b9c9-432e-adfe-4b30cade8931	9
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	ec3a3dcf-b9c9-432e-adfe-4b30cade8931	9
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	ec3a3dcf-b9c9-432e-adfe-4b30cade8931	9
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	5cf0f572-48fc-6a3a-e053-2991aa0a8437	6
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	6301febb-01aa-1af5-e053-2991aa0aa309	6
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	ab52b14d-345b-47ff-a832-465caddd3801	6
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	5cf0f572-48fc-6a3a-e053-2991aa0a8437	6
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	ab52b14d-345b-47ff-a832-465caddd3801	6
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	6301febb-01aa-1af5-e053-2991aa0aa309	6
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	ab52b14d-345b-47ff-a832-465caddd3801	6
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	6301febb-01aa-1af5-e053-2991aa0aa309	6
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	5cf0f572-48fc-6a3a-e053-2991aa0a8437	6
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	ab52b14d-345b-47ff-a832-465caddd3801	6
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	6301febb-01aa-1af5-e053-2991aa0aa309	6
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	5cf0f572-48fc-6a3a-e053-2991aa0a8437	6
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	2c0d0f9f-2df5-41f6-891f-454c8012ef26	5
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	2c0d0f9f-2df5-41f6-891f-454c8012ef26	5
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	2c0d0f9f-2df5-41f6-891f-454c8012ef26	5
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	2c0d0f9f-2df5-41f6-891f-454c8012ef26	5
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	54c73290-bd89-3453-e054-00144ff88e88	4
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	78641acd-eedf-4b68-bb18-da0874415f59	4
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	e04dfddd-6177-4c2e-8f42-acd65848e6e2	4
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	e04dfddd-6177-4c2e-8f42-acd65848e6e2	4
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	78641acd-eedf-4b68-bb18-da0874415f59	4
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	54c73290-bd89-3453-e054-00144ff88e88	4
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	78641acd-eedf-4b68-bb18-da0874415f59	4
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	54c73290-bd89-3453-e054-00144ff88e88	4
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	e04dfddd-6177-4c2e-8f42-acd65848e6e2	4
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	e04dfddd-6177-4c2e-8f42-acd65848e6e2	4
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	78641acd-eedf-4b68-bb18-da0874415f59	4
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	54c73290-bd89-3453-e054-00144ff88e88	4
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	1ac4540c-d0f7-70bc-e063-6394a90a0f7a	2
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	e1c02ef2-c0af-48da-aa52-3a494aa357ea	2
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	e1c02ef2-c0af-48da-aa52-3a494aa357ea	2
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	1ac4540c-d0f7-70bc-e063-6394a90a0f7a	2
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	1ac4540c-d0f7-70bc-e063-6394a90a0f7a	2
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	e1c02ef2-c0af-48da-aa52-3a494aa357ea	2
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	e1c02ef2-c0af-48da-aa52-3a494aa357ea	2
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	1ac4540c-d0f7-70bc-e063-6394a90a0f7a	2
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	11f56251-d913-4986-9dba-c2e4df8a3822	1
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2	1
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	509b932e-9229-42c0-8a4c-f3257ffdca49	1
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	d88a73c8-24d6-433e-a2c3-69b91e7be96a	1
309307	ciprofloxacin HCl 0.3 % Ophthalmic Solution	PSN	7dc89dd0-9bad-2639-e053-2a91aa0ad4d5	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	d88a73c8-24d6-433e-a2c3-69b91e7be96a	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	509b932e-9229-42c0-8a4c-f3257ffdca49	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	11f56251-d913-4986-9dba-c2e4df8a3822	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	7dc89dd0-9bad-2639-e053-2a91aa0ad4d5	1
309307	ciprofloxacin 3 MG/ML Ophthalmic Solution	SCD	2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	509b932e-9229-42c0-8a4c-f3257ffdca49	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	d88a73c8-24d6-433e-a2c3-69b91e7be96a	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	11f56251-d913-4986-9dba-c2e4df8a3822	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2	1
309307	ciprofloxacin 0.3 % Ophthalmic Solution	SY	7dc89dd0-9bad-2639-e053-2a91aa0ad4d5	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	d88a73c8-24d6-433e-a2c3-69b91e7be96a	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	509b932e-9229-42c0-8a4c-f3257ffdca49	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	7dc89dd0-9bad-2639-e053-2a91aa0ad4d5	1
309307	ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution	SY	11f56251-d913-4986-9dba-c2e4df8a3822	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-656-05	61314065605	1 BOTTLE, PLASTIC in 1 CARTON (61314-656-05) / 5 mL in 1 BOTTLE, PLASTIC	2004-05-07	0000-00-00	No	No	Current
61314-656-10	61314065610	1 BOTTLE, PLASTIC in 1 CARTON (61314-656-10) / 10 mL in 1 BOTTLE, PLASTIC	2004-05-07	0000-00-00	No	No	Current
61314-656-25	61314065625	1 BOTTLE, PLASTIC in 1 CARTON (61314-656-25) / 2.5 mL in 1 BOTTLE, PLASTIC	2004-05-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	Redpharm Drug	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	Preferred Pharmaceuticals Inc.	2026-03-27	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	REMEDYREPACK INC.	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	11
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-03-29	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile	NuCare Pharmaceuticals,Inc.	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	6
Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile	NuCare Pharmaceuticals,Inc.	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	6
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	A-S Medication Solutions	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	9
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	A-S Medication Solutions	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	13
Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile	NuCare Pharmaceuticals,Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	4
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile	Proficient Rx LP	2022-12-01	HUMAN PRESCRIPTION DRUG LABEL	4
CIPROFLOXACIN OPTH SOLUTION	DIRECT RX	2022-06-03	HUMAN PRESCRIPTION DRUG LABEL	12
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	Preferred Preferred Phamraceuticals Inc. Inc. \| PreferredPreferred Phamraceuticals Inc.	2020-04-20	HUMAN PRESCRIPTION DRUG LABEL	3
Ciprofloxacin Ophthalmic Solution 0.3% Sterile	Sandoz Inc \| Alcon Research LLC	2019-07-18	HUMAN PRESCRIPTION DRUG LABEL	6
Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile	Lake Erie Medical DBA Quality Care Products LLC	2019-02-14	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile	medsource pharmaceuticals	2018-12-24	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-21	HUMAN PRESCRIPTION DRUG LABEL	1
Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile	Unit Dose Services	2018-08-10	HUMAN PRESCRIPTION DRUG LABEL	2
Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile	STAT Rx USA LLC \| PSS World Medical Inc.	2012-10-11	HUMAN PRESCRIPTION DRUG LABEL	1
CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION 0.3% as base Sterile	Rebel Distributors Corp	2010-09-23	HUMAN PRESCRIPTION DRUG LABEL	1