FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
13107-077
11-digit product format
131070077
Labeler code
13107
Product ID
13107-077_c7605785-8db2-41eb-90e2-f12275b7b299
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA077859
Marketing category
ANDA
Marketing start
2009-08-01
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13107-077-012020-01-31C16284748780-19d75b9d0-5b6f-f424-e053-dadaa90a57ced54a97d5-3664-4ca5-bffd-8366c7255b73
13107-077-302020-01-31C16284748780-19d75b9d0-5b6f-f424-e053-dadaa90a57ced54a97d5-3664-4ca5-bffd-8366c7255b73
13107-077-992020-01-31C16284748780-19d75b9d0-5b6f-f424-e053-dadaa90a57ced54a97d5-3664-4ca5-bffd-8366c7255b73

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-077-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1008
13107-077-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED308
13107-077-99Ciprofloxacin1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-077-01EA - Each13107-077ee8386bd-7868-4953-b9b0-4f1c8839697412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]2
CIPROFLOXACINACTIVE INGREDIENT5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-077CIPROFLOXACIN (CIPROFLOXACIN ) TABLET, FILM COATED CIPROFLOXACIN TABLET, FILM COATED [AUROLIFE PHARMA LLC]8Legacy NDC, 3 package rows20120605_d54a97d5-3664-4ca5-bffd-8366c7255b73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNd54a97d5-3664-4ca5-bffd-8366c7255b738
309309ciprofloxacin 500 MG Oral TabletPSNd54a97d5-3664-4ca5-bffd-8366c7255b738
197511ciprofloxacin 250 MG Oral TabletSCDd54a97d5-3664-4ca5-bffd-8366c7255b738
309309ciprofloxacin 500 MG Oral TabletSCDd54a97d5-3664-4ca5-bffd-8366c7255b738
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd54a97d5-3664-4ca5-bffd-8366c7255b738
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd54a97d5-3664-4ca5-bffd-8366c7255b738
309309ciprofloxacin 500 MG Oral TabletPSN489c5c7d-75e3-4b98-b7d5-3c61e2f98adf2
309309ciprofloxacin 500 MG Oral TabletSCD489c5c7d-75e3-4b98-b7d5-3c61e2f98adf2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY489c5c7d-75e3-4b98-b7d5-3c61e2f98adf2
309309ciprofloxacin 500 MG Oral TabletPSN4213db46-f17e-48f5-aa18-114b2b8143701
309309ciprofloxacin 500 MG Oral TabletPSN6d8d72fe-e89c-4e08-9ca1-ec64c48902051
309309ciprofloxacin 500 MG Oral TabletSCD4213db46-f17e-48f5-aa18-114b2b8143701
309309ciprofloxacin 500 MG Oral TabletSCD6d8d72fe-e89c-4e08-9ca1-ec64c48902051
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4213db46-f17e-48f5-aa18-114b2b8143701
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY6d8d72fe-e89c-4e08-9ca1-ec64c48902051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13107-077-0113107007701100 in 1 BOTTLEHistorical
13107-077-301310700773030 in 1 BOTTLEHistorical
13107-077-99131070077991000 in 1 BOTTLEHistorical