CIPROFLOXACIN

Product NDC
61919-491
11-digit product format
619190491
Labeler code
61919
Product ID
61919-491_e08b85e9-c5b7-29cf-e053-2a95a90aab40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
NDA019992
Marketing category
NDA
Marketing start
2018-03-15
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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-491-052025-01-31C16284748780-1d6a99b39-a01d-a426-e053-dadaa90af4c2CIPROFLOXACIN OPTH SOLUTION
61919-491-252025-01-31C16284748780-1d6a99b39-a01d-a426-e053-dadaa90af4c2CIPROFLOXACIN OPTH SOLUTION
61919-491-502025-01-31C16284748780-1d6a99b39-a01d-a426-e053-dadaa90af4c2CIPROFLOXACIN OPTH SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-491-05CIPROFLOXACIN5 mL in 1 BOTTLESOLUTION/ DROPS512
61919-491-25CIPROFLOXACIN1 mL in 1 BOTTLESOLUTION/ DROPS112
61919-491-50CIPROFLOXACIN1 mL in 1 BOTTLESOLUTION/ DROPS112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-491-05ML - Milliliter61919-491ee7e3704-c910-416a-b7e0-d990f0b45c1b12022-07-06
61919-491-25ML - Milliliter61919-49184904c9d-fd03-4a79-ae2e-288b53e1803c12019-08-06
61919-491-50ML - Milliliter61919-49197056a10-94ac-4ed7-ab8f-d3660717a56512019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-491CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE SOLUTION) SOLUTION/ DROPS [DIRECT RX]12Legacy NDC, 3 package rows20220604_0fa41584-2f85-4ed9-9042-a713cd7ecc59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN0fa41584-2f85-4ed9-9042-a713cd7ecc5912
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD0fa41584-2f85-4ed9-9042-a713cd7ecc5912
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY0fa41584-2f85-4ed9-9042-a713cd7ecc5912
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY0fa41584-2f85-4ed9-9042-a713cd7ecc5912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-491-05619190491055 mL in 1 BOTTLE (61919-491-05) 5 ml2018-03-150000-00-00NoNoCurrent
61919-491-25619190491251 mL in 1 BOTTLE (61919-491-25) 1 ml2018-03-150000-00-00NoNoCurrent
61919-491-50619190491501 mL in 1 BOTTLE (61919-491-50) 1 ml2018-03-150000-00-00NoNoCurrent