FDA.reportPublic FDA data

ciprofloxacin

Product NDC
50090-4217
11-digit product format
500904217
Labeler code
50090
Product ID
50090-4217_6241a0e1-3ec2-4a77-bb87-89a75bf2b999
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
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
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui309307

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
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
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product 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
50090-4217-02023-02-07C16284748780-1f386c64a-040b-0266-e053-dadaa90a7c1aCiprofloxacin ophthalmic solution USP 0.3% Sterile
50090-4217-02023-01-30C16284748780-1f386c64a-040b-0266-e053-dadaa90a7c1aCiprofloxacin ophthalmic solution USP 0.3% Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4217-0ciprofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION59
50090-4217-0ciprofloxacin1 in 1 CARTONSOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4217-0ML - Milliliter50090-4217bd71b85a-e924-4830-aea4-e4f7fa43228912021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4217CIPROFLOXACIN SOLUTION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20241003_766251ac-2040-4a79-9ca5-a1e5f1e01cb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN766251ac-2040-4a79-9ca5-a1e5f1e01cb59
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD766251ac-2040-4a79-9ca5-a1e5f1e01cb59
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY766251ac-2040-4a79-9ca5-a1e5f1e01cb59
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY766251ac-2040-4a79-9ca5-a1e5f1e01cb59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4217-0500904217001 BOTTLE, PLASTIC in 1 CARTON (50090-4217-0) / 5 mL in 1 BOTTLE, PLASTIC2019-03-260000-00-00NoNoCurrent