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

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui309307

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-656-05Ciprofloxacin Hydrochloride1 in 1 CARTONSOLUTION/ DROPS16
61314-656-05Ciprofloxacin Hydrochloride5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS56
61314-656-10Ciprofloxacin Hydrochloride1 in 1 CARTONSOLUTION/ DROPS16
61314-656-10Ciprofloxacin Hydrochloride10 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS106
61314-656-25Ciprofloxacin Hydrochloride2.5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS2.56
61314-656-25Ciprofloxacin Hydrochloride1 in 1 CARTONSOLUTION/ DROPS16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-656-05ML - Milliliter61314-65685c76317-eba1-4f81-b0d2-887f901b07b812012-07-24
61314-656-10ML - Milliliter61314-6568375b475-200a-48ff-bf99-098a651a8dbc12012-07-24
61314-656-25ML - Milliliter61314-65671aaf077-ded6-48b2-a3b0-921dfa274c0f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1
acetic acidINACTIVE INGREDIENTQ40Q9N063PCIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1
mannitolINACTIVE INGREDIENT3OWL53L36ACIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1
sodium acetateINACTIVE INGREDIENT4550K0SC9BCIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1
waterINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN HYDROCHLORIDE SOLUTION [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-656CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]6Current NDC, Legacy NDC, 6 package rows20220702_ab52b14d-345b-47ff-a832-465caddd3801.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN694b79f6-599f-4a71-bf02-d0d09767a73513
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD694b79f6-599f-4a71-bf02-d0d09767a73513
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY694b79f6-599f-4a71-bf02-d0d09767a73513
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY694b79f6-599f-4a71-bf02-d0d09767a73513
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN0fa41584-2f85-4ed9-9042-a713cd7ecc5912
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD0fa41584-2f85-4ed9-9042-a713cd7ecc5912
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY0fa41584-2f85-4ed9-9042-a713cd7ecc5912
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY0fa41584-2f85-4ed9-9042-a713cd7ecc5912
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSNa2cec2cc-729b-4baa-8df1-c3f70847a48310
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDa2cec2cc-729b-4baa-8df1-c3f70847a48310
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYa2cec2cc-729b-4baa-8df1-c3f70847a48310
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYa2cec2cc-729b-4baa-8df1-c3f70847a48310
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSNec3a3dcf-b9c9-432e-adfe-4b30cade89319
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDec3a3dcf-b9c9-432e-adfe-4b30cade89319
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYec3a3dcf-b9c9-432e-adfe-4b30cade89319
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYec3a3dcf-b9c9-432e-adfe-4b30cade89319
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN5cf0f572-48fc-6a3a-e053-2991aa0a84376
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN6301febb-01aa-1af5-e053-2991aa0aa3096
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSNab52b14d-345b-47ff-a832-465caddd38016
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD5cf0f572-48fc-6a3a-e053-2991aa0a84376
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDab52b14d-345b-47ff-a832-465caddd38016
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD6301febb-01aa-1af5-e053-2991aa0aa3096
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYab52b14d-345b-47ff-a832-465caddd38016
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY6301febb-01aa-1af5-e053-2991aa0aa3096
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY5cf0f572-48fc-6a3a-e053-2991aa0a84376
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYab52b14d-345b-47ff-a832-465caddd38016
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY6301febb-01aa-1af5-e053-2991aa0aa3096
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY5cf0f572-48fc-6a3a-e053-2991aa0a84376
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN2c0d0f9f-2df5-41f6-891f-454c8012ef265
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD2c0d0f9f-2df5-41f6-891f-454c8012ef265
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY2c0d0f9f-2df5-41f6-891f-454c8012ef265
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY2c0d0f9f-2df5-41f6-891f-454c8012ef265
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN54c73290-bd89-3453-e054-00144ff88e884
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN78641acd-eedf-4b68-bb18-da0874415f594
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSNe04dfddd-6177-4c2e-8f42-acd65848e6e24
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDe04dfddd-6177-4c2e-8f42-acd65848e6e24
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD78641acd-eedf-4b68-bb18-da0874415f594
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD54c73290-bd89-3453-e054-00144ff88e884
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY78641acd-eedf-4b68-bb18-da0874415f594
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY54c73290-bd89-3453-e054-00144ff88e884
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYe04dfddd-6177-4c2e-8f42-acd65848e6e24
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYe04dfddd-6177-4c2e-8f42-acd65848e6e24
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY78641acd-eedf-4b68-bb18-da0874415f594
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY54c73290-bd89-3453-e054-00144ff88e884
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN1ac4540c-d0f7-70bc-e063-6394a90a0f7a2
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSNe1c02ef2-c0af-48da-aa52-3a494aa357ea2
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDe1c02ef2-c0af-48da-aa52-3a494aa357ea2
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD1ac4540c-d0f7-70bc-e063-6394a90a0f7a2
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY1ac4540c-d0f7-70bc-e063-6394a90a0f7a2
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYe1c02ef2-c0af-48da-aa52-3a494aa357ea2
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYe1c02ef2-c0af-48da-aa52-3a494aa357ea2
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY1ac4540c-d0f7-70bc-e063-6394a90a0f7a2
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN11f56251-d913-4986-9dba-c2e4df8a38221
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN2ef01a91-e73e-46d6-a6f9-d7d6dae91ea21
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN509b932e-9229-42c0-8a4c-f3257ffdca491
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSNd88a73c8-24d6-433e-a2c3-69b91e7be96a1
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN7dc89dd0-9bad-2639-e053-2a91aa0ad4d51
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDd88a73c8-24d6-433e-a2c3-69b91e7be96a1
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD509b932e-9229-42c0-8a4c-f3257ffdca491
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD11f56251-d913-4986-9dba-c2e4df8a38221
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD7dc89dd0-9bad-2639-e053-2a91aa0ad4d51
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD2ef01a91-e73e-46d6-a6f9-d7d6dae91ea21
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY509b932e-9229-42c0-8a4c-f3257ffdca491
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYd88a73c8-24d6-433e-a2c3-69b91e7be96a1
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY11f56251-d913-4986-9dba-c2e4df8a38221
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY2ef01a91-e73e-46d6-a6f9-d7d6dae91ea21
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY7dc89dd0-9bad-2639-e053-2a91aa0ad4d51
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYd88a73c8-24d6-433e-a2c3-69b91e7be96a1
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY509b932e-9229-42c0-8a4c-f3257ffdca491
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY2ef01a91-e73e-46d6-a6f9-d7d6dae91ea21
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY7dc89dd0-9bad-2639-e053-2a91aa0ad4d51
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY11f56251-d913-4986-9dba-c2e4df8a38221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61314-656-05613140656051 BOTTLE, PLASTIC in 1 CARTON (61314-656-05) / 5 mL in 1 BOTTLE, PLASTIC2004-05-070000-00-00NoNoCurrent
61314-656-10613140656101 BOTTLE, PLASTIC in 1 CARTON (61314-656-10) / 10 mL in 1 BOTTLE, PLASTIC2004-05-070000-00-00NoNoCurrent
61314-656-25613140656251 BOTTLE, PLASTIC in 1 CARTON (61314-656-25) / 2.5 mL in 1 BOTTLE, PLASTIC2004-05-070000-00-00NoNoCurrent