FDA.reportPublic FDA data

Ciprofloxacin Hydrochloride

Product NDC
69367-386
11-digit product format
693670386
Labeler code
69367
Product ID
69367-386_e679760f-b4d3-4a21-9d47-40c2355bc2c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA076593
Marketing category
ANDA
Marketing start
2024-05-23
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 Hydrochloride
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
69367-386-01Ciprofloxacin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
69367-386-05Ciprofloxacin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-386-01EA - Each69367-3864865fa32-f4a5-4c32-93af-5e7db8b9741412024-07-12
69367-386-05EA - Each69367-386e5640a12-3f11-4b4c-9473-d0a7d779604612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-386CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20240605_c47250c2-bece-46b5-8b3b-b7c97d9005d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNb281a5c0-5f3e-4e6f-86ac-ed7794aac64c3
309309ciprofloxacin 500 MG Oral TabletSCDb281a5c0-5f3e-4e6f-86ac-ed7794aac64c3
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb281a5c0-5f3e-4e6f-86ac-ed7794aac64c3
197511ciprofloxacin 250 MG Oral TabletPSNc47250c2-bece-46b5-8b3b-b7c97d9005d81
309309ciprofloxacin 500 MG Oral TabletPSN6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb1
309309ciprofloxacin 500 MG Oral TabletPSNc47250c2-bece-46b5-8b3b-b7c97d9005d81
309309ciprofloxacin 500 MG Oral TabletPSN1057be77-00bb-4839-be3d-c8e11ae531a21
309309ciprofloxacin 500 MG Oral TabletPSN4972e902-e042-e947-e063-6394a90a1b701
309309ciprofloxacin 500 MG Oral TabletPSN42542f65-84a7-fdab-e063-6394a90a10951
309309ciprofloxacin 500 MG Oral TabletPSN30caadee-3255-e0e3-e063-6294a90a80611
197512ciprofloxacin 750 MG Oral TabletPSNc47250c2-bece-46b5-8b3b-b7c97d9005d81
197511ciprofloxacin 250 MG Oral TabletSCDc47250c2-bece-46b5-8b3b-b7c97d9005d81
309309ciprofloxacin 500 MG Oral TabletSCD30caadee-3255-e0e3-e063-6294a90a80611
309309ciprofloxacin 500 MG Oral TabletSCD1057be77-00bb-4839-be3d-c8e11ae531a21
309309ciprofloxacin 500 MG Oral TabletSCDc47250c2-bece-46b5-8b3b-b7c97d9005d81
309309ciprofloxacin 500 MG Oral TabletSCD42542f65-84a7-fdab-e063-6394a90a10951
309309ciprofloxacin 500 MG Oral TabletSCD6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb1
309309ciprofloxacin 500 MG Oral TabletSCD4972e902-e042-e947-e063-6394a90a1b701
197512ciprofloxacin 750 MG Oral TabletSCDc47250c2-bece-46b5-8b3b-b7c97d9005d81
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY30caadee-3255-e0e3-e063-6294a90a80611
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb1
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY1057be77-00bb-4839-be3d-c8e11ae531a21
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc47250c2-bece-46b5-8b3b-b7c97d9005d81
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4972e902-e042-e947-e063-6394a90a1b701
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY42542f65-84a7-fdab-e063-6394a90a10951
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSYc47250c2-bece-46b5-8b3b-b7c97d9005d81
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYc47250c2-bece-46b5-8b3b-b7c97d9005d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-386-0169367038601100 TABLET, FILM COATED in 1 BOTTLE (69367-386-01) 2024-05-23NoNoHistorical
69367-386-0569367038605500 TABLET, FILM COATED in 1 BOTTLE (69367-386-05) 2024-05-23NoNoHistorical