FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
43547-689
11-digit product format
435470689
Labeler code
43547
Product ID
43547-689_d02ca299-0a85-451c-990e-eb006905fd0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA208921
Marketing category
ANDA
Marketing start
2023-10-01
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
43547-689-10Ciprofloxacin100 in 1 BOTTLETABLET1003
43547-689-50Ciprofloxacin500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-689CIPROFLOXACIN (CIPROFOLXACIN) TABLET [SOLCO HEALTHCARE US, LLC]1Current NDC, 2 package rows20231013_b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNab16bacd-f73f-462e-82b2-b0abb1c49cec100
309309ciprofloxacin 500 MG Oral TabletSCDab16bacd-f73f-462e-82b2-b0abb1c49cec100
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYab16bacd-f73f-462e-82b2-b0abb1c49cec100
309309ciprofloxacin 500 MG Oral TabletPSNc527d138-e32c-418f-9573-a3d8a796279f10
309309ciprofloxacin 500 MG Oral TabletSCDc527d138-e32c-418f-9573-a3d8a796279f10
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc527d138-e32c-418f-9573-a3d8a796279f10
309309ciprofloxacin 500 MG Oral TabletPSN1b189dba-0493-c9b4-e063-6294a90a7d1e5
309309ciprofloxacin 500 MG Oral TabletSCD1b189dba-0493-c9b4-e063-6294a90a7d1e5
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY1b189dba-0493-c9b4-e063-6294a90a7d1e5
309309ciprofloxacin 500 MG Oral TabletPSN3253a41f-4f0a-5d83-e063-6294a90a890c4
309309ciprofloxacin 500 MG Oral TabletPSNa0eda476-1625-4e9e-bb76-4f1cf05562f04
309309ciprofloxacin 500 MG Oral TabletPSN351b41db-622f-a1eb-e063-6294a90a56674
309309ciprofloxacin 500 MG Oral TabletSCD3253a41f-4f0a-5d83-e063-6294a90a890c4
309309ciprofloxacin 500 MG Oral TabletSCDa0eda476-1625-4e9e-bb76-4f1cf05562f04
309309ciprofloxacin 500 MG Oral TabletSCD351b41db-622f-a1eb-e063-6294a90a56674
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3253a41f-4f0a-5d83-e063-6294a90a890c4
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY351b41db-622f-a1eb-e063-6294a90a56674
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa0eda476-1625-4e9e-bb76-4f1cf05562f04
197511ciprofloxacin 250 MG Oral TabletPSNb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
309309ciprofloxacin 500 MG Oral TabletPSN4425d454-210d-4b9f-88ad-6b32a9e0d3bd3
309309ciprofloxacin 500 MG Oral TabletPSNb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
309309ciprofloxacin 500 MG Oral TabletPSN24c43000-7620-3869-e063-6394a90a96313
197511ciprofloxacin 250 MG Oral TabletSCDb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
309309ciprofloxacin 500 MG Oral TabletSCD4425d454-210d-4b9f-88ad-6b32a9e0d3bd3
309309ciprofloxacin 500 MG Oral TabletSCD24c43000-7620-3869-e063-6394a90a96313
309309ciprofloxacin 500 MG Oral TabletSCDb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4425d454-210d-4b9f-88ad-6b32a9e0d3bd3
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY24c43000-7620-3869-e063-6394a90a96313
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
197511ciprofloxacin 250 MG Oral TabletPSNd38b5160-4c1c-41d9-8f13-f9f877778f9c2
197511ciprofloxacin 250 MG Oral TabletPSNc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
309309ciprofloxacin 500 MG Oral TabletPSNd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin 500 MG Oral TabletPSN288ea7b2-ecf2-e8e0-e063-6294a90a306a2
309309ciprofloxacin 500 MG Oral TabletPSN2b8288a2-18bf-423c-b175-33174be729d42
309309ciprofloxacin 500 MG Oral TabletPSNc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
309309ciprofloxacin 500 MG Oral TabletPSN0ce2221d-940f-4c07-ba2e-fccb491f6b9b2
197511ciprofloxacin 250 MG Oral TabletSCDc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
197511ciprofloxacin 250 MG Oral TabletSCDd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin 500 MG Oral TabletSCD0ce2221d-940f-4c07-ba2e-fccb491f6b9b2
309309ciprofloxacin 500 MG Oral TabletSCDc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
309309ciprofloxacin 500 MG Oral TabletSCDd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin 500 MG Oral TabletSCD2b8288a2-18bf-423c-b175-33174be729d42
309309ciprofloxacin 500 MG Oral TabletSCD288ea7b2-ecf2-e8e0-e063-6294a90a306a2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY2b8288a2-18bf-423c-b175-33174be729d42
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY288ea7b2-ecf2-e8e0-e063-6294a90a306a2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY0ce2221d-940f-4c07-ba2e-fccb491f6b9b2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin 500 MG Oral TabletPSN3134401f-72a3-6c37-e063-6294a90a8fa91
309309ciprofloxacin 500 MG Oral TabletPSN2d324cb1-8567-55e5-e063-6294a90aa5d91
309309ciprofloxacin 500 MG Oral TabletSCD3134401f-72a3-6c37-e063-6294a90a8fa91
309309ciprofloxacin 500 MG Oral TabletSCD2d324cb1-8567-55e5-e063-6294a90aa5d91
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3134401f-72a3-6c37-e063-6294a90a8fa91
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY2d324cb1-8567-55e5-e063-6294a90aa5d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-689-1043547068910100 TABLET in 1 BOTTLE (43547-689-10) 100 tablet2023-10-01NoNoCurrent
43547-689-5043547068950500 TABLET in 1 BOTTLE (43547-689-50) 500 tablet2023-10-01NoNoCurrent