FDA.reportPublic FDA data

Ciprofloxacin Hydrochloride

Product NDC
68071-3351
11-digit product format
680713351
Labeler code
68071
Product ID
68071-3351_1ce8f03a-6915-908c-e063-6394a90a270c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA019992
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2004-05-07
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 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
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
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3351-32023-06-30C16284748780-1ba0f9c33-36ed-a910-e053-dadaa90a0b85Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile
68071-3351-32023-01-30C16284748780-1ba0f9c33-36ed-a910-e053-dadaa90a0b85Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile
68071-3351-32021-02-12C16284748780-1ba0f9c33-36ed-a910-e053-dadaa90a0b85Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile
68071-3351-32021-01-29C16284748780-1ba0f9c33-36ed-a910-e053-dadaa90a0b85Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3351-3Ciprofloxacin Hydrochloride10 mL in 1 BOXSOLUTION/ DROPS104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3351CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240711_54c73290-bd89-3453-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN54c73290-bd89-3453-e054-00144ff88e884
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD54c73290-bd89-3453-e054-00144ff88e884
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY54c73290-bd89-3453-e054-00144ff88e884
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY54c73290-bd89-3453-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3351-36807133510310 mL in 1 BOX (68071-3351-3) 10 ml2017-07-200000-00-00NoNoCurrent