FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
12634-769
11-digit product format
126340769
Labeler code
12634
Product ID
12634-769_27310a8d-5bb6-4624-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA076558
Marketing category
ANDA
Marketing start
2004-06-09
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
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
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
12634-769-002020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-012020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-542020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-572020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-592020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-612020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-662020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-672020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-712020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-742020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-782020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-802020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-842020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-852020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-912020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-962020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP
12634-769-982020-01-31C16284748780-19d75b9d0-d693-f424-e053-dadaa90a57ceCiprofloxacin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-769-00Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED101
12634-769-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1001
12634-769-54Ciprofloxacin14 in 1 BLISTER PACKTABLET, FILM COATED141
12634-769-57Ciprofloxacin20 in 1 BLISTER PACKTABLET, FILM COATED201
12634-769-59Ciprofloxacin30 in 1 BLISTER PACKTABLET, FILM COATED301
12634-769-61Ciprofloxacin10 in 1 BLISTER PACKTABLET, FILM COATED101
12634-769-66Ciprofloxacin6 in 1 BLISTER PACKTABLET, FILM COATED61
12634-769-67Ciprofloxacin7 in 1 BLISTER PACKTABLET, FILM COATED71
12634-769-71Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED301
12634-769-74Ciprofloxacin24 in 1 BOTTLETABLET, FILM COATED241
12634-769-78Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED281
12634-769-80Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201
12634-769-84Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141
12634-769-85Ciprofloxacin15 in 1 BOTTLETABLET, FILM COATED151
12634-769-91Ciprofloxacin1 in 1 BLISTER PACKTABLET, FILM COATED11
12634-769-96Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED61
12634-769-98Ciprofloxacin8 in 1 BOTTLETABLET, FILM COATED81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-769CIPROFLOXACIN TABLET, FILM COATED [APOTHECA INC.]1Legacy NDC, 17 package rows20151218_2730ec3d-e1a4-3cbc-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN2730ec3d-e1a4-3cbc-e054-00144ff8d46c1
309309ciprofloxacin 500 MG Oral TabletSCD2730ec3d-e1a4-3cbc-e054-00144ff8d46c1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY2730ec3d-e1a4-3cbc-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-769-001263407690010 in 1 BOTTLEHistorical
12634-769-0112634076901100 in 1 BOTTLEHistorical
12634-769-541263407695414 in 1 BLISTER PACKHistorical
12634-769-571263407695720 in 1 BLISTER PACKHistorical
12634-769-591263407695930 in 1 BLISTER PACKHistorical
12634-769-611263407696110 in 1 BLISTER PACKHistorical
12634-769-66126340769666 in 1 BLISTER PACKHistorical
12634-769-67126340769677 in 1 BLISTER PACKHistorical
12634-769-711263407697130 in 1 BOTTLEHistorical
12634-769-741263407697424 in 1 BOTTLEHistorical
12634-769-781263407697828 in 1 BOTTLEHistorical
12634-769-801263407698020 in 1 BOTTLEHistorical
12634-769-841263407698414 in 1 BOTTLEHistorical
12634-769-851263407698515 in 1 BOTTLEHistorical
12634-769-91126340769911 in 1 BLISTER PACKHistorical
12634-769-96126340769966 in 1 BOTTLEHistorical
12634-769-98126340769988 in 1 BOTTLEHistorical