FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
16252-516
11-digit product format
162520516
Labeler code
16252
Product ID
16252-516_ca204c4b-0e44-47d0-9fe0-6947a714315d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA076794
Marketing category
ANDA
Marketing start
2006-11-01
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16252-516-05Ciprofloxacin50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16252-516-05EA - Each16252-516617622d4-e222-48df-80a2-b7f6e8961ac512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
TALCINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
crospovidoneINACTIVE INGREDIENT68401960MKCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
polyvinyl alcoholINACTIVE INGREDIENT532B59J990CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
talcINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
crospovidoneINACTIVE INGREDIENT68401960MKCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
polyvinyl alcoholINACTIVE INGREDIENT532B59J990CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16252-516CIPROFLOXACIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]36Legacy NDC, 1 package rows20250410_3e4402d4-e0d3-9846-3e81-ed46f34137fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN3e4402d4-e0d3-9846-3e81-ed46f34137fe36
309309ciprofloxacin 500 MG Oral TabletPSN3e4402d4-e0d3-9846-3e81-ed46f34137fe36
197512ciprofloxacin 750 MG Oral TabletPSN3e4402d4-e0d3-9846-3e81-ed46f34137fe36
197511ciprofloxacin 250 MG Oral TabletSCD3e4402d4-e0d3-9846-3e81-ed46f34137fe36
309309ciprofloxacin 500 MG Oral TabletSCD3e4402d4-e0d3-9846-3e81-ed46f34137fe36
197512ciprofloxacin 750 MG Oral TabletSCD3e4402d4-e0d3-9846-3e81-ed46f34137fe36
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3e4402d4-e0d3-9846-3e81-ed46f34137fe36
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY3e4402d4-e0d3-9846-3e81-ed46f34137fe36
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY3e4402d4-e0d3-9846-3e81-ed46f34137fe36
197511ciprofloxacin 250 MG Oral TabletPSN64d0b20a-cecd-474e-a0a1-8f8853500def6
309309ciprofloxacin 500 MG Oral TabletPSN64d0b20a-cecd-474e-a0a1-8f8853500def6
197512ciprofloxacin 750 MG Oral TabletPSN64d0b20a-cecd-474e-a0a1-8f8853500def6
197511ciprofloxacin 250 MG Oral TabletSCD64d0b20a-cecd-474e-a0a1-8f8853500def6
309309ciprofloxacin 500 MG Oral TabletSCD64d0b20a-cecd-474e-a0a1-8f8853500def6
197512ciprofloxacin 750 MG Oral TabletSCD64d0b20a-cecd-474e-a0a1-8f8853500def6
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY64d0b20a-cecd-474e-a0a1-8f8853500def6
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY64d0b20a-cecd-474e-a0a1-8f8853500def6
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY64d0b20a-cecd-474e-a0a1-8f8853500def6
197512ciprofloxacin 750 MG Oral TabletPSNe659af2b-b240-4afe-894e-962ae9c3d87f3
197512ciprofloxacin 750 MG Oral TabletSCDe659af2b-b240-4afe-894e-962ae9c3d87f3
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSYe659af2b-b240-4afe-894e-962ae9c3d87f3
197511ciprofloxacin 250 MG Oral TabletPSN99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
309309ciprofloxacin 500 MG Oral TabletPSN99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197512ciprofloxacin 750 MG Oral TabletPSN99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197511ciprofloxacin 250 MG Oral TabletSCD99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
309309ciprofloxacin 500 MG Oral TabletSCD99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197512ciprofloxacin 750 MG Oral TabletSCD99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY99a81fda-81dc-40b3-b55a-165b6e4ca4ee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16252-516-051625205160550 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16252-516-05) 2006-11-010000-00-00NoNoCurrent