FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
58657-675
11-digit product format
586570675
Labeler code
58657
Product ID
58657-675_41b40647-01ce-1916-e063-6394a90aaadd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA208921
Marketing category
ANDA
Marketing start
2020-08-12
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, 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
58657-675-01Ciprofloxacin100 in 1 BOTTLETABLET, COATED1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-675CIPROFLOXACIN TABLET, COATED [METHOD PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 1 package rows20241201_acb03e72-ce94-58c5-e053-2a95a90a683a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN5af16acc-51ce-41ed-b1c4-6b3fb38ef515104
197511ciprofloxacin 250 MG Oral TabletSCD5af16acc-51ce-41ed-b1c4-6b3fb38ef515104
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY5af16acc-51ce-41ed-b1c4-6b3fb38ef515104
197511ciprofloxacin 250 MG Oral TabletPSNacb03e72-ce94-58c5-e053-2a95a90a683a8
309309ciprofloxacin 500 MG Oral TabletPSNacb03e72-ce94-58c5-e053-2a95a90a683a8
197511ciprofloxacin 250 MG Oral TabletSCDacb03e72-ce94-58c5-e053-2a95a90a683a8
309309ciprofloxacin 500 MG Oral TabletSCDacb03e72-ce94-58c5-e053-2a95a90a683a8
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYacb03e72-ce94-58c5-e053-2a95a90a683a8
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYacb03e72-ce94-58c5-e053-2a95a90a683a8
197511ciprofloxacin 250 MG Oral TabletPSN18414c5a-8153-44f7-b27a-90c290af0a235
197511ciprofloxacin 250 MG Oral TabletSCD18414c5a-8153-44f7-b27a-90c290af0a235
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY18414c5a-8153-44f7-b27a-90c290af0a235
197511ciprofloxacin 250 MG Oral TabletPSNf3c2de8f-ed0e-6d08-e053-2a95a90a44b13
197511ciprofloxacin 250 MG Oral TabletSCDf3c2de8f-ed0e-6d08-e053-2a95a90a44b13
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYf3c2de8f-ed0e-6d08-e053-2a95a90a44b13
197511ciprofloxacin 250 MG Oral TabletPSNd88a22f4-2f61-17f2-e053-2995a90acd142
197511ciprofloxacin 250 MG Oral TabletPSN201f5cea-f2b5-42c2-a0ef-b1af4c7a36622
197511ciprofloxacin 250 MG Oral TabletPSNbf52e242-199b-4206-e053-2a95a90a1eb72
197511ciprofloxacin 250 MG Oral TabletSCDd88a22f4-2f61-17f2-e053-2995a90acd142
197511ciprofloxacin 250 MG Oral TabletSCD201f5cea-f2b5-42c2-a0ef-b1af4c7a36622
197511ciprofloxacin 250 MG Oral TabletSCDbf52e242-199b-4206-e053-2a95a90a1eb72
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYbf52e242-199b-4206-e053-2a95a90a1eb72
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd88a22f4-2f61-17f2-e053-2995a90acd142
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY201f5cea-f2b5-42c2-a0ef-b1af4c7a36622
197511ciprofloxacin 250 MG Oral TabletPSN6b5fe0aa-c74f-42f3-a84a-1cb16009aa801
197511ciprofloxacin 250 MG Oral TabletPSNf2044f0a-9839-5289-e053-2995a90aa13d1
197511ciprofloxacin 250 MG Oral TabletPSN8f4d4bbb-a8f5-492f-8b2a-22be57719ac91
197511ciprofloxacin 250 MG Oral TabletSCD6b5fe0aa-c74f-42f3-a84a-1cb16009aa801
197511ciprofloxacin 250 MG Oral TabletSCDf2044f0a-9839-5289-e053-2995a90aa13d1
197511ciprofloxacin 250 MG Oral TabletSCD8f4d4bbb-a8f5-492f-8b2a-22be57719ac91
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY6b5fe0aa-c74f-42f3-a84a-1cb16009aa801
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYf2044f0a-9839-5289-e053-2995a90aa13d1
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY8f4d4bbb-a8f5-492f-8b2a-22be57719ac91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-675-0158657067501100 TABLET, COATED in 1 BOTTLE (58657-675-01) 2020-08-120000-00-00NoNoCurrent