Ciprofloxacin

Product NDC
55111-422
11-digit product format
551110422
Labeler code
55111
Product ID
55111-422_52f816f4-05ac-1372-790b-a02129c1d94e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA077902
Marketing category
ANDA
Marketing start
2007-03-26
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN
Active strength
288 mg/1; mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-422-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1005
55111-422-05Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5005
55111-422-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
55111-422-78Ciprofloxacin100 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE1005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacinACTIVE INGREDIENT5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
crospovidoneINACTIVE INGREDIENT68401960MKCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
succinic acidINACTIVE INGREDIENTAB6MNQ6J6LCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-422CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5Legacy NDC, 4 package rows20120228_4ab110e4-7b91-42aa-8052-f24cd79293f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403921ciprofloxacin 1000 MG 24HR Extended Release Oral TabletPSN4ab110e4-7b91-42aa-8052-f24cd79293f05
359383ciprofloxacin 500 MG 24HR Extended Release Oral TabletPSN4ab110e4-7b91-42aa-8052-f24cd79293f05
40392124 HR ciprofloxacin 1000 MG Extended Release Oral TabletSCD4ab110e4-7b91-42aa-8052-f24cd79293f05
35938324 HR ciprofloxacin 500 MG Extended Release Oral TabletSCD4ab110e4-7b91-42aa-8052-f24cd79293f05
403921ciprofloxacin 1000 MG 24 HR Extended Release Oral TabletSY4ab110e4-7b91-42aa-8052-f24cd79293f05
359383ciprofloxacin 500 MG 24 HR Extended Release Oral TabletSY4ab110e4-7b91-42aa-8052-f24cd79293f05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55111-422-0155111042201100 in 1 BOTTLEHistorical
55111-422-0555111042205500 in 1 BOTTLEHistorical
55111-422-305511104223030 in 1 BOTTLEHistorical
55111-422-7855111042278100 in 1 BOX, UNIT-DOSEHistorical