FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
65862-077
11-digit product format
658620077
Labeler code
65862
Product ID
65862-077_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
2027-02-28
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 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 HYDROCHLORIDE500 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
65862-077-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED10033
65862-077-05Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED50033
65862-077-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED2033
65862-077-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED3033
65862-077-99Ciprofloxacin1000 in 1 BOTTLETABLET, FILM COATED100033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-077-01EA - Each65862-0774c5116a1-ac78-42ce-afe6-94318a4676d812012-07-24
65862-077-05EA - Each65862-07729b51b15-5176-4c00-8aff-f49fd56b31fc12021-11-09

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
65862-077CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]32Current NDC, Legacy NDC, 5 package rows20250501_2b3b6a9f-259c-4736-b88f-f49d1eb64286.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNac87e3c7-1e51-4dd1-8b75-dec6536810e3104
309309ciprofloxacin 500 MG Oral TabletSCDac87e3c7-1e51-4dd1-8b75-dec6536810e3104
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYac87e3c7-1e51-4dd1-8b75-dec6536810e3104
309309ciprofloxacin 500 MG Oral TabletPSNa2ffa81a-86c5-40b9-8fa0-c889801ef47938
309309ciprofloxacin 500 MG Oral TabletSCDa2ffa81a-86c5-40b9-8fa0-c889801ef47938
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa2ffa81a-86c5-40b9-8fa0-c889801ef47938
309309ciprofloxacin 500 MG Oral TabletPSNd290a840-6c60-435f-a46b-6d9ef7b9e5f334
309309ciprofloxacin 500 MG Oral TabletSCDd290a840-6c60-435f-a46b-6d9ef7b9e5f334
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd290a840-6c60-435f-a46b-6d9ef7b9e5f334
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
309309ciprofloxacin 500 MG Oral TabletPSN9d83b127-ef13-4b2c-aa30-0f54937dc24018
309309ciprofloxacin 500 MG Oral TabletSCD9d83b127-ef13-4b2c-aa30-0f54937dc24018
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY9d83b127-ef13-4b2c-aa30-0f54937dc24018
309309ciprofloxacin 500 MG Oral TabletPSN4d5afeff-3917-43e1-9d12-d70ccab00dcc11
309309ciprofloxacin 500 MG Oral TabletSCD4d5afeff-3917-43e1-9d12-d70ccab00dcc11
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4d5afeff-3917-43e1-9d12-d70ccab00dcc11
309309ciprofloxacin 500 MG Oral TabletPSNd8b21832-b74f-4f85-a304-b907c9e01e7210
309309ciprofloxacin 500 MG Oral TabletSCDd8b21832-b74f-4f85-a304-b907c9e01e7210
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd8b21832-b74f-4f85-a304-b907c9e01e7210
309309ciprofloxacin 500 MG Oral TabletPSNa7e5174a-dd01-6050-e053-2a95a90add3f7
309309ciprofloxacin 500 MG Oral TabletPSN76dedf59-46be-1be0-e053-2991aa0a1c367
309309ciprofloxacin 500 MG Oral TabletSCD76dedf59-46be-1be0-e053-2991aa0a1c367
309309ciprofloxacin 500 MG Oral TabletSCDa7e5174a-dd01-6050-e053-2a95a90add3f7
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY76dedf59-46be-1be0-e053-2991aa0a1c367
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa7e5174a-dd01-6050-e053-2a95a90add3f7
309309ciprofloxacin 500 MG Oral TabletPSN7a7cc017-fc08-3118-e053-2991aa0ad7af5
309309ciprofloxacin 500 MG Oral TabletPSNe237dd23-faf3-1765-e053-2a95a90ae62d5
309309ciprofloxacin 500 MG Oral TabletPSNf80ab01d-2533-1b4c-e053-6294a90a6e6a5
309309ciprofloxacin 500 MG Oral TabletSCDf80ab01d-2533-1b4c-e053-6294a90a6e6a5
309309ciprofloxacin 500 MG Oral TabletSCDe237dd23-faf3-1765-e053-2a95a90ae62d5
309309ciprofloxacin 500 MG Oral TabletSCD7a7cc017-fc08-3118-e053-2991aa0ad7af5
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY7a7cc017-fc08-3118-e053-2991aa0ad7af5
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYe237dd23-faf3-1765-e053-2a95a90ae62d5
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf80ab01d-2533-1b4c-e053-6294a90a6e6a5
309309ciprofloxacin 500 MG Oral TabletPSN1cb05412-372e-4b49-92e1-532caa05f38f4
309309ciprofloxacin 500 MG Oral TabletPSNec337816-4f48-4d04-b91d-60f9f5f634da4
309309ciprofloxacin 500 MG Oral TabletPSN4fe686e7-b9bb-7450-e054-00144ff8d46c4
309309ciprofloxacin 500 MG Oral TabletSCD1cb05412-372e-4b49-92e1-532caa05f38f4
309309ciprofloxacin 500 MG Oral TabletSCDec337816-4f48-4d04-b91d-60f9f5f634da4
309309ciprofloxacin 500 MG Oral TabletSCD4fe686e7-b9bb-7450-e054-00144ff8d46c4
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4fe686e7-b9bb-7450-e054-00144ff8d46c4
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY1cb05412-372e-4b49-92e1-532caa05f38f4
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYec337816-4f48-4d04-b91d-60f9f5f634da4
309309ciprofloxacin 500 MG Oral TabletPSNf2937a87-2e10-3728-e053-2a95a90a9eb93
309309ciprofloxacin 500 MG Oral TabletSCDf2937a87-2e10-3728-e053-2a95a90a9eb93
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf2937a87-2e10-3728-e053-2a95a90a9eb93
309309ciprofloxacin 500 MG Oral TabletPSNd40f0560-fc57-4f00-9f6d-ae7e2a2743302
309309ciprofloxacin 500 MG Oral TabletPSNda86ea21-084a-4a78-94fb-840391e5f1f62
309309ciprofloxacin 500 MG Oral TabletPSNb4c17302-590f-4de0-ad57-8bb050d9aa8a2
309309ciprofloxacin 500 MG Oral TabletPSNae77a5c0-a2ae-770c-e053-2a95a90a6a962
309309ciprofloxacin 500 MG Oral TabletSCDae77a5c0-a2ae-770c-e053-2a95a90a6a962
309309ciprofloxacin 500 MG Oral TabletSCDda86ea21-084a-4a78-94fb-840391e5f1f62
309309ciprofloxacin 500 MG Oral TabletSCDd40f0560-fc57-4f00-9f6d-ae7e2a2743302
309309ciprofloxacin 500 MG Oral TabletSCDb4c17302-590f-4de0-ad57-8bb050d9aa8a2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYda86ea21-084a-4a78-94fb-840391e5f1f62
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd40f0560-fc57-4f00-9f6d-ae7e2a2743302
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb4c17302-590f-4de0-ad57-8bb050d9aa8a2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYae77a5c0-a2ae-770c-e053-2a95a90a6a962
309309ciprofloxacin 500 MG Oral TabletPSN4e74496f-4dca-4471-be32-c0a14bc627501
309309ciprofloxacin 500 MG Oral TabletSCD4e74496f-4dca-4471-be32-c0a14bc627501
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4e74496f-4dca-4471-be32-c0a14bc627501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-077-0165862007701100 TABLET, FILM COATED in 1 BOTTLE (65862-077-01) 2007-04-262027-02-28NoNoCurrent
65862-077-0565862007705500 TABLET, FILM COATED in 1 BOTTLE (65862-077-05) 2007-04-262027-02-28NoNoCurrent
65862-077-206586200772020 TABLET, FILM COATED in 1 BOTTLE (65862-077-20) 2007-04-260000-00-00NoNoCurrent
65862-077-306586200773030 TABLET, FILM COATED in 1 BOTTLE (65862-077-30) 2007-04-260000-00-00NoNoCurrent
65862-077-99658620077991000 TABLET, FILM COATED in 1 BOTTLE (65862-077-99) 2007-04-260000-00-00NoNoCurrent