ciprofloxacin

Product NDC
45865-979
11-digit product format
458650979
Labeler code
45865
Product ID
45865-979_9af1178f-baaf-4972-e053-2995a90a8222
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
medsource pharmaceuticals
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
2020-12-31
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
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
45865-979-012023-01-30C16284748780-1f386c64a-3f81-0266-e053-dadaa90a7c1aCiprofloxacin ophthalmic solution USP 0.3% as base Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-979-01ciprofloxacin1 in 1 CARTONSOLUTION11
45865-979-01ciprofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-979CIPROFLOXACIN SOLUTION [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20191231_9af1178f-baae-4972-e053-2995a90a8222.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN9af1178f-baae-4972-e053-2995a90a82221
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD9af1178f-baae-4972-e053-2995a90a82221
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY9af1178f-baae-4972-e053-2995a90a82221
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY9af1178f-baae-4972-e053-2995a90a82221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-979-01458650979011 BOTTLE, PLASTIC in 1 CARTON (45865-979-01) > 5 mL in 1 BOTTLE, PLASTIC2019-12-110000-00-00NoNoCurrent