Ciprofloxacin HCl Ophthalmic

Product NDC
59390-217
11-digit product format
593900217
Labeler code
59390
Product ID
59390-217_f31149b7-60fc-4cef-8270-5eb8ff2b42bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Altaire Pharmaceuticals Inc.
Application
ANDA204613
Marketing category
ANDA
Marketing start
2018-05-04
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 HCl Ophthalmic
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
59390-217-02Ciprofloxacin HCl Ophthalmic2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.57
59390-217-05Ciprofloxacin HCl Ophthalmic5 mL in 1 BOTTLE, PLASTICSOLUTION57
59390-217-10Ciprofloxacin HCl Ophthalmic10 mL in 1 BOTTLE, PLASTICSOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59390-217-02ML - Milliliter59390-2173c53f537-2229-4add-a8f9-15ffd80d582c12019-01-24
59390-217-05ML - Milliliter59390-21717b017bc-c43b-4b99-9019-748bddf5f7f012019-01-24
59390-217-10ML - Milliliter59390-21734aea2ab-2a9a-4593-b3ec-fcf28cee72d112019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59390-217CIPROFLOXACIN HCL OPHTHALMIC (CIPROFLOXACIN HYDROCHLORIDE) SOLUTION [ALTAIRE PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 3 package rows20221101_41363a06-d6f5-4bc6-b0e9-34e5616ae387.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN41363a06-d6f5-4bc6-b0e9-34e5616ae3877
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD41363a06-d6f5-4bc6-b0e9-34e5616ae3877
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY41363a06-d6f5-4bc6-b0e9-34e5616ae3877
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY41363a06-d6f5-4bc6-b0e9-34e5616ae3877

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59390-217-02593900217022.5 mL in 1 BOTTLE, PLASTIC (59390-217-02) 2.5 ml2018-05-040000-00-00NoNoCurrent
59390-217-05593900217055 mL in 1 BOTTLE, PLASTIC (59390-217-05) 5 ml2018-05-040000-00-00NoNoCurrent
59390-217-105939002171010 mL in 1 BOTTLE, PLASTIC (59390-217-10) 10 ml2018-05-040000-00-00NoNoCurrent