FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
58657-676
11-digit product format
586570676
Labeler code
58657
Product ID
58657-676_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
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, 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
58657-676-01Ciprofloxacin100 in 1 BOTTLETABLET, COATED1008
58657-676-50Ciprofloxacin500 in 1 BOTTLETABLET, COATED5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-676CIPROFLOXACIN TABLET, COATED [METHOD PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 2 package rows20241201_acb03e72-ce94-58c5-e053-2a95a90a683a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNa05035e1-f941-4f7c-9321-91dd50ab149b104
309309ciprofloxacin 500 MG Oral TabletSCDa05035e1-f941-4f7c-9321-91dd50ab149b104
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa05035e1-f941-4f7c-9321-91dd50ab149b104
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
309309ciprofloxacin 500 MG Oral TabletPSNbf8d4359-a850-97b7-e053-2a95a90aa66a2
309309ciprofloxacin 500 MG Oral TabletPSN17435f05-f04d-e792-e063-6294a90af1452
309309ciprofloxacin 500 MG Oral TabletPSN82d568d3-9637-4a21-a56e-cc9dc210dee42
309309ciprofloxacin 500 MG Oral TabletPSNc2d8dcc9-23b0-75bb-e053-2995a90a02c82
309309ciprofloxacin 500 MG Oral TabletPSNf6debb60-d885-230b-e053-6394a90ad73a2
309309ciprofloxacin 500 MG Oral TabletSCDc2d8dcc9-23b0-75bb-e053-2995a90a02c82
309309ciprofloxacin 500 MG Oral TabletSCDf6debb60-d885-230b-e053-6394a90ad73a2
309309ciprofloxacin 500 MG Oral TabletSCDbf8d4359-a850-97b7-e053-2a95a90aa66a2
309309ciprofloxacin 500 MG Oral TabletSCD82d568d3-9637-4a21-a56e-cc9dc210dee42
309309ciprofloxacin 500 MG Oral TabletSCD17435f05-f04d-e792-e063-6294a90af1452
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYbf8d4359-a850-97b7-e053-2a95a90aa66a2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc2d8dcc9-23b0-75bb-e053-2995a90a02c82
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY82d568d3-9637-4a21-a56e-cc9dc210dee42
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY17435f05-f04d-e792-e063-6294a90af1452
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf6debb60-d885-230b-e053-6394a90ad73a2
309309ciprofloxacin 500 MG Oral TabletPSNc32ccb5f-b9d7-0aff-e053-2995a90afe6d1
309309ciprofloxacin 500 MG Oral TabletPSNf3c3181e-4e52-3070-e053-2a95a90aa92f1
309309ciprofloxacin 500 MG Oral TabletSCDc32ccb5f-b9d7-0aff-e053-2995a90afe6d1
309309ciprofloxacin 500 MG Oral TabletSCDf3c3181e-4e52-3070-e053-2a95a90aa92f1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc32ccb5f-b9d7-0aff-e053-2995a90afe6d1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf3c3181e-4e52-3070-e053-2a95a90aa92f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-676-0158657067601100 TABLET, COATED in 1 BOTTLE (58657-676-01) 2020-08-120000-00-00NoNoCurrent
58657-676-5058657067650500 TABLET, COATED in 1 BOTTLE (58657-676-50) 2020-08-120000-00-00NoNoCurrent