ciprofloxacin

Product NDC
55545-1011
11-digit product format
555451011
Labeler code
55545
Product ID
55545-1011_3ed875b7-75eb-4ba1-9a36-80f13fb73454
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
FDC Limited
Application
ANDA077568
Marketing category
ANDA
Marketing start
2018-11-01
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1011-1ciprofloxacin1 in 1 CARTONSOLUTION11
55545-1011-1ciprofloxacin2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.51
55545-1011-2ciprofloxacin1 in 1 CARTONSOLUTION11
55545-1011-2ciprofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION51
55545-1011-3ciprofloxacin10 mL in 1 BOTTLE, PLASTICSOLUTION101
55545-1011-3ciprofloxacin1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1011CIPROFLOXACIN SOLUTION [FDC LIMITED]1Legacy NDC, 6 package rows20181101_0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc1
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc1
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc1
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55545-1011-1555451011011 in 1 CARTONHistorical
55545-1011-2555451011021 in 1 CARTONHistorical
55545-1011-35554510110310 mL in 1 BOTTLE, PLASTIC10 mlHistorical