FDA.reportPublic FDA data

Ciprofloxacin Otic

Product NDC
42195-550
11-digit product format
421950550
Labeler code
42195
Product ID
42195-550_613cf17e-578a-4530-ac73-179d72a9e415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIPROFLOXACIN
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Xspire Pharma, Llc
Application
NDA021918
Marketing category
NDA
Marketing start
2012-08-27
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
1 mg/.25mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42195-550IInactivated by FDA2026-07-31
excluded packagepackage42195-55042195-550-14IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021918-001CETRAXALCIPROFLOXACIN HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OTICABRLD, RS2009-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021918-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021918-001CETRAXALEQ 0.2% BASESOLUTION/DROPS / OTICABRLD, RS2009-05-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021918-001AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42195-550-142026-01-29C16284748780-1ba0f9c33-1f73-a910-e053-dadaa90a0b85THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN OTIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN OTIC SOLUTION. Ciprofloxacin Otic Solution, 0.2% Initial U.S. Approval: 1987
42195-550-142024-04-21C16284748780-1ba0f9c33-1f73-a910-e053-dadaa90a0b85THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN OTIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN OTIC SOLUTION. Ciprofloxacin Otic Solution, 0.2% Initial U.S. Approval: 1987
42195-550-142024-01-30C16284748780-1ba0f9c33-1f73-a910-e053-dadaa90a0b85THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN OTIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN OTIC SOLUTION. Ciprofloxacin Otic Solution, 0.2% Initial U.S. Approval: 1987
42195-550-142021-02-02C16284748780-1ba0f9c33-1f73-a910-e053-dadaa90a0b85THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN OTIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN OTIC SOLUTION. Ciprofloxacin Otic Solution, 0.2% Initial U.S. Approval: 1987
42195-550-142021-01-29C16284748780-1ba0f9c33-1f73-a910-e053-dadaa90a0b85THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN OTIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN OTIC SOLUTION. Ciprofloxacin Otic Solution, 0.2% Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42195-550-14Ciprofloxacin Otic0.25 mL in 1 CONTAINERSOLUTION/ DROPS0.256
42195-550-14Ciprofloxacin Otic14 in 1 CARTONSOLUTION/ DROPS146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42195-550-14EA - Each42195-55090d06427-bfba-418f-bc41-4845bde7cc0612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN OTIC (CIPROFLOXACIN) SOLUTION/ DROPS [XSPIRE PHARMA]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN OTIC (CIPROFLOXACIN) SOLUTION/ DROPS [XSPIRE PHARMA]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCIPROFLOXACIN OTIC (CIPROFLOXACIN) SOLUTION/ DROPS [XSPIRE PHARMA]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECIPROFLOXACIN OTIC (CIPROFLOXACIN) SOLUTION/ DROPS [XSPIRE PHARMA]1
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN OTIC (CIPROFLOXACIN) SOLUTION/ DROPS [XSPIRE PHARMA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42195-550CIPROFLOXACIN OTIC (CIPROFLOXACIN) SOLUTION/ DROPS [XSPIRE PHARMA, LLC]6Legacy NDC, 2 package rows20241011_d0125acf-1879-452d-ba29-c0f753653789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848956ciprofloxacin HCl 0.2 % Otic SolutionPSNd0125acf-1879-452d-ba29-c0f7536537896
848956ciprofloxacin 2 MG/ML Otic SolutionSCDd0125acf-1879-452d-ba29-c0f7536537896
848956ciprofloxacin 0.2 % Otic SolutionSYd0125acf-1879-452d-ba29-c0f7536537896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42195-550-144219505501414 CONTAINER in 1 CARTON (42195-550-14) > .25 mL in 1 CONTAINER14 container2012-08-270000-00-00NoNoCurrent