FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
0143-9927
11-digit product format
001439927
Labeler code
0143
Product ID
0143-9927_570d11c9-d12f-47fd-be83-37fa26d1262f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076558
Marketing category
ANDA
Marketing start
2004-06-09
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0143-9927-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED10027
0143-9927-05Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED50027
0143-9927-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED3027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9927-01EA - Each0143-99273fd9b9e7-dce7-4a88-aa79-7e0999f4181a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
TALCINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN TABLET, FILM COATED [WEST-WARD PHARMACEUTICALS CORP]10
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
TALCINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN TABLET, FILM COATED [READYMEDS]8
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9927CIPROFLOXACIN TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC.]27Current NDC, Legacy NDC, 3 package rows20241228_3b3d22dc-df09-4910-8c9b-1204eeedbd68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN4f600112-168a-4a58-9914-7c01f71894da108
197511ciprofloxacin 250 MG Oral TabletSCD4f600112-168a-4a58-9914-7c01f71894da108
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY4f600112-168a-4a58-9914-7c01f71894da108
197511ciprofloxacin 250 MG Oral TabletPSNd275175c-691a-4d09-bbb7-50ee819e672730
197511ciprofloxacin 250 MG Oral TabletSCDd275175c-691a-4d09-bbb7-50ee819e672730
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd275175c-691a-4d09-bbb7-50ee819e672730
197511ciprofloxacin 250 MG Oral TabletPSNf67d727f-b9ca-aec0-e053-2995a90aab6928
197511ciprofloxacin 250 MG Oral TabletSCDf67d727f-b9ca-aec0-e053-2995a90aab6928
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYf67d727f-b9ca-aec0-e053-2995a90aab6928
197511ciprofloxacin 250 MG Oral TabletPSN5723eaf9-8659-4730-b792-4e4c33690ccb27
197511ciprofloxacin 250 MG Oral TabletPSN3b3d22dc-df09-4910-8c9b-1204eeedbd6827
309309ciprofloxacin 500 MG Oral TabletPSN3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197512ciprofloxacin 750 MG Oral TabletPSN5723eaf9-8659-4730-b792-4e4c33690ccb27
197512ciprofloxacin 750 MG Oral TabletPSN3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197511ciprofloxacin 250 MG Oral TabletSCD3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197511ciprofloxacin 250 MG Oral TabletSCD5723eaf9-8659-4730-b792-4e4c33690ccb27
309309ciprofloxacin 500 MG Oral TabletSCD3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197512ciprofloxacin 750 MG Oral TabletSCD3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197512ciprofloxacin 750 MG Oral TabletSCD5723eaf9-8659-4730-b792-4e4c33690ccb27
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY5723eaf9-8659-4730-b792-4e4c33690ccb27
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY5723eaf9-8659-4730-b792-4e4c33690ccb27
197511ciprofloxacin 250 MG Oral TabletPSNc08b37c3-5f01-47ed-9508-02813bbd008b10
197511ciprofloxacin 250 MG Oral TabletSCDc08b37c3-5f01-47ed-9508-02813bbd008b10
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc08b37c3-5f01-47ed-9508-02813bbd008b10
197511ciprofloxacin 250 MG Oral TabletPSN8916b85c-9004-4e26-a34d-b0e6a65e6a248
309309ciprofloxacin 500 MG Oral TabletPSN8916b85c-9004-4e26-a34d-b0e6a65e6a248
197511ciprofloxacin 250 MG Oral TabletSCD8916b85c-9004-4e26-a34d-b0e6a65e6a248
309309ciprofloxacin 500 MG Oral TabletSCD8916b85c-9004-4e26-a34d-b0e6a65e6a248
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY8916b85c-9004-4e26-a34d-b0e6a65e6a248
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY8916b85c-9004-4e26-a34d-b0e6a65e6a248
197511ciprofloxacin 250 MG Oral TabletPSN4e7bef83-aa63-3a6b-e054-00144ff88e887
197511ciprofloxacin 250 MG Oral TabletSCD4e7bef83-aa63-3a6b-e054-00144ff88e887
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY4e7bef83-aa63-3a6b-e054-00144ff88e887
197511ciprofloxacin 250 MG Oral TabletPSN159454fc-11c7-36b9-e054-00144ff88e883
309309ciprofloxacin 500 MG Oral TabletPSN159454fc-11c7-36b9-e054-00144ff88e883
197511ciprofloxacin 250 MG Oral TabletSCD159454fc-11c7-36b9-e054-00144ff88e883
309309ciprofloxacin 500 MG Oral TabletSCD159454fc-11c7-36b9-e054-00144ff88e883
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY159454fc-11c7-36b9-e054-00144ff88e883
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY159454fc-11c7-36b9-e054-00144ff88e883
197511ciprofloxacin 250 MG Oral TabletPSNd358eb18-f4d0-e9ba-e053-2a95a90a435d2
197511ciprofloxacin 250 MG Oral TabletSCDd358eb18-f4d0-e9ba-e053-2a95a90a435d2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd358eb18-f4d0-e9ba-e053-2a95a90a435d2
197511ciprofloxacin 250 MG Oral TabletPSNc3cffc88-5eb3-6e18-e053-2995a90a14231
197511ciprofloxacin 250 MG Oral TabletPSNc4311673-23c7-2099-e053-2a95a90ad3f11
197511ciprofloxacin 250 MG Oral TabletPSNb116b1da-a7ab-3e2e-e053-2995a90a5cd81
197511ciprofloxacin 250 MG Oral TabletPSN1bb1d26e-fad0-4338-8948-3f095d5817a61
197511ciprofloxacin 250 MG Oral TabletSCDc3cffc88-5eb3-6e18-e053-2995a90a14231
197511ciprofloxacin 250 MG Oral TabletSCDc4311673-23c7-2099-e053-2a95a90ad3f11
197511ciprofloxacin 250 MG Oral TabletSCD1bb1d26e-fad0-4338-8948-3f095d5817a61
197511ciprofloxacin 250 MG Oral TabletSCDb116b1da-a7ab-3e2e-e053-2995a90a5cd81
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYb116b1da-a7ab-3e2e-e053-2995a90a5cd81
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc3cffc88-5eb3-6e18-e053-2995a90a14231
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc4311673-23c7-2099-e053-2a95a90ad3f11
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY1bb1d26e-fad0-4338-8948-3f095d5817a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9927-0100143992701100 TABLET, FILM COATED in 1 BOTTLE (0143-9927-01) 2004-06-090000-00-00NoNoCurrent
0143-9927-0500143992705500 TABLET, FILM COATED in 1 BOTTLE (0143-9927-05) 2004-06-090000-00-00NoNoCurrent
0143-9927-300014399273030 TABLET, FILM COATED in 1 BOTTLE (0143-9927-30) 2004-06-090000-00-00NoNoCurrent