FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
0143-9928
11-digit product format
001439928
Labeler code
0143
Product ID
0143-9928_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
500 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 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
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
0143-9928-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED10027
0143-9928-05Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED50027
0143-9928-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED3027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9928CIPROFLOXACIN 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
309309ciprofloxacin 500 MG Oral TabletPSN3b9b15f7-354b-4049-982b-f6f31751a88534
309309ciprofloxacin 500 MG Oral TabletSCD3b9b15f7-354b-4049-982b-f6f31751a88534
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3b9b15f7-354b-4049-982b-f6f31751a88534
197511ciprofloxacin 250 MG Oral TabletPSN3b3d22dc-df09-4910-8c9b-1204eeedbd6827
309309ciprofloxacin 500 MG Oral TabletPSNfa32aafd-e3f5-4be6-9413-c7663c1c2cec27
309309ciprofloxacin 500 MG Oral TabletPSN3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197512ciprofloxacin 750 MG Oral TabletPSN3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197511ciprofloxacin 250 MG Oral TabletSCD3b3d22dc-df09-4910-8c9b-1204eeedbd6827
309309ciprofloxacin 500 MG Oral TabletSCDfa32aafd-e3f5-4be6-9413-c7663c1c2cec27
309309ciprofloxacin 500 MG Oral TabletSCD3b3d22dc-df09-4910-8c9b-1204eeedbd6827
197512ciprofloxacin 750 MG Oral TabletSCD3b3d22dc-df09-4910-8c9b-1204eeedbd6827
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYfa32aafd-e3f5-4be6-9413-c7663c1c2cec27
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3b3d22dc-df09-4910-8c9b-1204eeedbd6827
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
309309ciprofloxacin 500 MG Oral TabletPSN2e1addcf-6d5b-46c8-812b-558fd847f00516
309309ciprofloxacin 500 MG Oral TabletSCD2e1addcf-6d5b-46c8-812b-558fd847f00516
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY2e1addcf-6d5b-46c8-812b-558fd847f00516
309309ciprofloxacin 500 MG Oral TabletPSN44b6cefc-7638-4437-95e7-8f239f66a9d414
309309ciprofloxacin 500 MG Oral TabletSCD44b6cefc-7638-4437-95e7-8f239f66a9d414
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY44b6cefc-7638-4437-95e7-8f239f66a9d414
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 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
309309ciprofloxacin 500 MG Oral TabletPSNd23e359d-6d12-38f6-e053-2a95a90a0a882
309309ciprofloxacin 500 MG Oral TabletPSNca8f9570-3237-e269-e053-2995a90a49ba2
309309ciprofloxacin 500 MG Oral TabletSCDca8f9570-3237-e269-e053-2995a90a49ba2
309309ciprofloxacin 500 MG Oral TabletSCDd23e359d-6d12-38f6-e053-2a95a90a0a882
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYca8f9570-3237-e269-e053-2995a90a49ba2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd23e359d-6d12-38f6-e053-2a95a90a0a882
309309ciprofloxacin 500 MG Oral TabletPSNca3c5dd5-d15c-62ea-e053-2995a90a24171
309309ciprofloxacin 500 MG Oral TabletPSNd39b4230-1026-f2be-e053-2995a90a9b6f1
309309ciprofloxacin 500 MG Oral TabletPSNcfc1963b-7a48-4129-b747-897a9d6de14c1
309309ciprofloxacin 500 MG Oral TabletPSN1cf7cc57-0577-3ec9-e063-6294a90ae4a91
309309ciprofloxacin 500 MG Oral TabletSCDcfc1963b-7a48-4129-b747-897a9d6de14c1
309309ciprofloxacin 500 MG Oral TabletSCDd39b4230-1026-f2be-e053-2995a90a9b6f1
309309ciprofloxacin 500 MG Oral TabletSCDca3c5dd5-d15c-62ea-e053-2995a90a24171
309309ciprofloxacin 500 MG Oral TabletSCD1cf7cc57-0577-3ec9-e063-6294a90ae4a91
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYcfc1963b-7a48-4129-b747-897a9d6de14c1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY1cf7cc57-0577-3ec9-e063-6294a90ae4a91
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd39b4230-1026-f2be-e053-2995a90a9b6f1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYca3c5dd5-d15c-62ea-e053-2995a90a24171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9928-0100143992801100 TABLET, FILM COATED in 1 BOTTLE (0143-9928-01) 2004-06-090000-00-00NoNoCurrent
0143-9928-0500143992805500 TABLET, FILM COATED in 1 BOTTLE (0143-9928-05) 2004-06-090000-00-00NoNoCurrent
0143-9928-300014399283030 TABLET, FILM COATED in 1 BOTTLE (0143-9928-30) 2004-06-090000-00-00NoNoCurrent