FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
65862-076
11-digit product format
658620076
Labeler code
65862
Product ID
65862-076_9e7eb1ac-3e09-4b4c-8ce1-ab16c3102a10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
2027-01-31
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511, 197512, 309309

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
65862-076-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED10033
65862-076-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED2033
65862-076-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED3033
65862-076-99Ciprofloxacin1000 in 1 BOTTLETABLET, FILM COATED100033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-076-01EA - Each65862-076654d9327-acd7-41e8-8968-dc3cae7f3abe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-076CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]32Current NDC, Legacy NDC, 4 package rows20250501_2b3b6a9f-259c-4736-b88f-f49d1eb64286.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN2b3b6a9f-259c-4736-b88f-f49d1eb6428633
309309ciprofloxacin 500 MG Oral TabletPSN2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197512ciprofloxacin 750 MG Oral TabletPSN2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197511ciprofloxacin 250 MG Oral TabletSCD2b3b6a9f-259c-4736-b88f-f49d1eb6428633
309309ciprofloxacin 500 MG Oral TabletSCD2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197512ciprofloxacin 750 MG Oral TabletSCD2b3b6a9f-259c-4736-b88f-f49d1eb6428633
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY2b3b6a9f-259c-4736-b88f-f49d1eb6428633
197511ciprofloxacin 250 MG Oral TabletPSN4dd69fb7-802a-4278-a730-c722a3ca352122
197511ciprofloxacin 250 MG Oral TabletSCD4dd69fb7-802a-4278-a730-c722a3ca352122
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY4dd69fb7-802a-4278-a730-c722a3ca352122
197511ciprofloxacin 250 MG Oral TabletPSN686a2ae7-dbc1-ccbf-e053-2991aa0a55254
197511ciprofloxacin 250 MG Oral TabletSCD686a2ae7-dbc1-ccbf-e053-2991aa0a55254
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY686a2ae7-dbc1-ccbf-e053-2991aa0a55254
197511ciprofloxacin 250 MG Oral TabletPSN2f123a2c-3f94-ca2d-e063-6394a90aff683
197511ciprofloxacin 250 MG Oral TabletSCD2f123a2c-3f94-ca2d-e063-6394a90aff683
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY2f123a2c-3f94-ca2d-e063-6394a90aff683
197511ciprofloxacin 250 MG Oral TabletPSN9ee1f252-a64e-4b72-a6f7-60298e8272222
197511ciprofloxacin 250 MG Oral TabletPSNcef015d0-b228-42b3-9b9b-eda2045d15dd2
197511ciprofloxacin 250 MG Oral TabletSCD9ee1f252-a64e-4b72-a6f7-60298e8272222
197511ciprofloxacin 250 MG Oral TabletSCDcef015d0-b228-42b3-9b9b-eda2045d15dd2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY9ee1f252-a64e-4b72-a6f7-60298e8272222
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYcef015d0-b228-42b3-9b9b-eda2045d15dd2
197511ciprofloxacin 250 MG Oral TabletPSN043e4beb-5dc0-2fdb-e063-6294a90afded1
197511ciprofloxacin 250 MG Oral TabletPSN3ab54ca0-1b12-d0f5-e063-6394a90a95751
197511ciprofloxacin 250 MG Oral TabletSCD3ab54ca0-1b12-d0f5-e063-6394a90a95751
197511ciprofloxacin 250 MG Oral TabletSCD043e4beb-5dc0-2fdb-e063-6294a90afded1
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY3ab54ca0-1b12-d0f5-e063-6394a90a95751
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY043e4beb-5dc0-2fdb-e063-6294a90afded1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-076-0165862007601100 TABLET, FILM COATED in 1 BOTTLE (65862-076-01) 2007-04-262027-01-31NoNoCurrent
65862-076-206586200762020 TABLET, FILM COATED in 1 BOTTLE (65862-076-20) 2007-04-260000-00-00NoNoCurrent
65862-076-306586200763030 TABLET, FILM COATED in 1 BOTTLE (65862-076-30) 2007-04-260000-00-00NoNoCurrent
65862-076-99658620076991000 TABLET, FILM COATED in 1 BOTTLE (65862-076-99) 2007-04-260000-00-00NoNoCurrent