FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
43547-688
11-digit product format
435470688
Labeler code
43547
Product ID
43547-688_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
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
43547-688-10Ciprofloxacin100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-688CIPROFLOXACIN (CIPROFOLXACIN) TABLET [SOLCO HEALTHCARE US, LLC]1Current NDC, 1 package rows20231013_b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN3b3c0874-90b7-deda-e063-6394a90a78028
197511ciprofloxacin 250 MG Oral TabletSCD3b3c0874-90b7-deda-e063-6394a90a78028
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY3b3c0874-90b7-deda-e063-6394a90a78028
197511ciprofloxacin 250 MG Oral TabletPSN4edc4fda-7834-46cc-a0ed-22f117e6e10b5
197511ciprofloxacin 250 MG Oral TabletSCD4edc4fda-7834-46cc-a0ed-22f117e6e10b5
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY4edc4fda-7834-46cc-a0ed-22f117e6e10b5
197511ciprofloxacin 250 MG Oral TabletPSN24760182-4be8-9f43-e063-6294a90a269e4
197511ciprofloxacin 250 MG Oral TabletSCD24760182-4be8-9f43-e063-6294a90a269e4
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY24760182-4be8-9f43-e063-6294a90a269e4
197511ciprofloxacin 250 MG Oral TabletPSNb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
197511ciprofloxacin 250 MG Oral TabletPSN3b0af0f2-1d33-1ffe-e063-6394a90aca7c3
309309ciprofloxacin 500 MG Oral TabletPSNb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
197511ciprofloxacin 250 MG Oral TabletSCDb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
197511ciprofloxacin 250 MG Oral TabletSCD3b0af0f2-1d33-1ffe-e063-6394a90aca7c3
309309ciprofloxacin 500 MG Oral TabletSCDb6dcfcef-d4ec-4463-a6b5-192cd8c7c0c33
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 (as ciprofloxacin HCl 297 MG) Oral TabletSY3b0af0f2-1d33-1ffe-e063-6394a90aca7c3
197511ciprofloxacin 250 MG Oral TabletPSN9f00ae9d-8707-4275-9eba-2ed72db8aea12
197511ciprofloxacin 250 MG Oral TabletPSNc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
197511ciprofloxacin 250 MG Oral TabletPSNc9108da9-c271-4e9e-a035-8dd3019e8cf32
197511ciprofloxacin 250 MG Oral TabletPSNcfe9e173-1d3a-4455-a9d3-fb953bebbe372
197511ciprofloxacin 250 MG Oral TabletPSNd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin 500 MG Oral TabletPSNc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
309309ciprofloxacin 500 MG Oral TabletPSNd38b5160-4c1c-41d9-8f13-f9f877778f9c2
197511ciprofloxacin 250 MG Oral TabletSCDc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
197511ciprofloxacin 250 MG Oral TabletSCDc9108da9-c271-4e9e-a035-8dd3019e8cf32
197511ciprofloxacin 250 MG Oral TabletSCDcfe9e173-1d3a-4455-a9d3-fb953bebbe372
197511ciprofloxacin 250 MG Oral TabletSCDd38b5160-4c1c-41d9-8f13-f9f877778f9c2
197511ciprofloxacin 250 MG Oral TabletSCD9f00ae9d-8707-4275-9eba-2ed72db8aea12
309309ciprofloxacin 500 MG Oral TabletSCDc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
309309ciprofloxacin 500 MG Oral TabletSCDd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd38b5160-4c1c-41d9-8f13-f9f877778f9c2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY9f00ae9d-8707-4275-9eba-2ed72db8aea12
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYcfe9e173-1d3a-4455-a9d3-fb953bebbe372
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc9108da9-c271-4e9e-a035-8dd3019e8cf32
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd38b5160-4c1c-41d9-8f13-f9f877778f9c2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc4eecdf8-9e50-4e44-aca1-b9c19317d52a2
197511ciprofloxacin 250 MG Oral TabletPSN41206a0f-7a5b-6a12-e063-6394a90a58b11
197511ciprofloxacin 250 MG Oral TabletPSN15755a35-e29a-47c1-89ab-e6645bb3ade91
197511ciprofloxacin 250 MG Oral TabletPSN238284a8-b38e-82af-e063-6394a90a79e11
197511ciprofloxacin 250 MG Oral TabletPSN2d6ad813-7773-9e20-e063-6294a90a112d1
197511ciprofloxacin 250 MG Oral TabletPSN2efbda2a-fc97-b7c5-e063-6294a90a362d1
197511ciprofloxacin 250 MG Oral TabletPSN348e810c-e572-f3d2-e063-6394a90a08551
197511ciprofloxacin 250 MG Oral TabletSCD2efbda2a-fc97-b7c5-e063-6294a90a362d1
197511ciprofloxacin 250 MG Oral TabletSCD2d6ad813-7773-9e20-e063-6294a90a112d1
197511ciprofloxacin 250 MG Oral TabletSCD348e810c-e572-f3d2-e063-6394a90a08551
197511ciprofloxacin 250 MG Oral TabletSCD15755a35-e29a-47c1-89ab-e6645bb3ade91
197511ciprofloxacin 250 MG Oral TabletSCD41206a0f-7a5b-6a12-e063-6394a90a58b11
197511ciprofloxacin 250 MG Oral TabletSCD238284a8-b38e-82af-e063-6394a90a79e11
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY15755a35-e29a-47c1-89ab-e6645bb3ade91
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY238284a8-b38e-82af-e063-6394a90a79e11
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY2d6ad813-7773-9e20-e063-6294a90a112d1
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY2efbda2a-fc97-b7c5-e063-6294a90a362d1
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY348e810c-e572-f3d2-e063-6394a90a08551
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY41206a0f-7a5b-6a12-e063-6394a90a58b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-688-1043547068810100 TABLET in 1 BOTTLE (43547-688-10) 100 tablet2023-10-01NoNoCurrent