Ciprofloxacin

Product NDC
33261-614
11-digit product format
332610614
Labeler code
33261
Product ID
33261-614_dc08c947-6dde-4f8b-ac36-46a390f99a7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076555
Marketing category
ANDA
Marketing start
2018-01-18
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
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product 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
33261-614-012020-01-31C16284748780-19d75b9d0-631f-f424-e053-dadaa90a57ceCiprofloxacin Ophthalmic Solution, USP 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-614-01Ciprofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-614-01ML - Milliliter33261-614fb14915d-5d46-4487-ab4f-71c362b1371412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-614CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180821_b7910edd-2037-40a8-b24b-6fd4752f9ef0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSNb7910edd-2037-40a8-b24b-6fd4752f9ef01
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDb7910edd-2037-40a8-b24b-6fd4752f9ef01
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYb7910edd-2037-40a8-b24b-6fd4752f9ef01
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYb7910edd-2037-40a8-b24b-6fd4752f9ef01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-614-01332610614015 mL in 1 BOTTLE, DROPPER5 mlHistorical