Ciprofloxacin

Product NDC
50090-5628
11-digit product format
500905628
Labeler code
50090
Product ID
50090-5628_9287ec23-2311-479f-8334-8ecab3f2443b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076126
Marketing category
ANDA
Marketing start
2009-10-10
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
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
50090-5628-02023-01-30C16284748780-1f386c649-b536-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
50090-5628-12023-01-30C16284748780-1f386c649-b536-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
50090-5628-32023-01-30C16284748780-1f386c649-b536-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
50090-5628-42023-01-30C16284748780-1f386c649-b536-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
50090-5628-52023-01-30C16284748780-1f386c649-b536-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
50090-5628-72023-01-30C16284748780-1f386c649-b536-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987
50090-5628-82023-01-30C16284748780-1f386c649-b536-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5628-0Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201
50090-5628-1Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141
50090-5628-3Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED61
50090-5628-4Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED281
50090-5628-5Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED101
50090-5628-7Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED301
50090-5628-8Ciprofloxacin1 in 1 BOTTLETABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5628-0EA - Each50090-5628a93842d0-096e-49ee-8c05-27f7f075430e12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5628CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 7 package rows20210909_e1afd2dd-6f01-4798-a9d8-0125c38f1e42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNe1afd2dd-6f01-4798-a9d8-0125c38f1e421
309309ciprofloxacin 500 MG Oral TabletSCDe1afd2dd-6f01-4798-a9d8-0125c38f1e421
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYe1afd2dd-6f01-4798-a9d8-0125c38f1e421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5628-05009056280020 TABLET, FILM COATED in 1 BOTTLE (50090-5628-0) 2021-09-010000-00-00NoNoCurrent
50090-5628-15009056280114 TABLET, FILM COATED in 1 BOTTLE (50090-5628-1) 2021-09-090000-00-00NoNoCurrent
50090-5628-3500905628036 TABLET, FILM COATED in 1 BOTTLE (50090-5628-3) 2021-09-010000-00-00NoNoCurrent
50090-5628-45009056280428 TABLET, FILM COATED in 1 BOTTLE (50090-5628-4) 2021-09-010000-00-00NoNoCurrent
50090-5628-55009056280510 TABLET, FILM COATED in 1 BOTTLE (50090-5628-5) 2021-09-010000-00-00NoNoCurrent
50090-5628-75009056280730 TABLET, FILM COATED in 1 BOTTLE (50090-5628-7) 2021-09-010000-00-00NoNoCurrent
50090-5628-8500905628081 TABLET, FILM COATED in 1 BOTTLE (50090-5628-8) 2021-09-010000-00-00NoNoCurrent