FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
51407-165
11-digit product format
514070165
Labeler code
51407
Product ID
51407-165_2ee94e9b-43b8-e3d5-e063-6394a90ae89b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA076126
Marketing category
ANDA
Marketing start
2004-06-09
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
Rxcui309309

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
51407-165-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1009
51407-165-05Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED5009
51407-165-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED209
51407-165-28Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED289

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-165CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 4 package rows20250411_d17b0e87-b555-4dfb-e053-2a95a90aa5ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNd17b0e87-b555-4dfb-e053-2a95a90aa5ef9
309309ciprofloxacin 500 MG Oral TabletSCDd17b0e87-b555-4dfb-e053-2a95a90aa5ef9
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd17b0e87-b555-4dfb-e053-2a95a90aa5ef9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-165-0151407016501100 TABLET, FILM COATED in 1 BOTTLE (51407-165-01) 2021-10-050000-00-00NoNoCurrent
51407-165-0551407016505500 TABLET, FILM COATED in 1 BOTTLE (51407-165-05) 2021-10-050000-00-00NoNoCurrent
51407-165-205140701652020 TABLET, FILM COATED in 1 BOTTLE (51407-165-20) 2023-02-06NoNoCurrent
51407-165-285140701652828 TABLET, FILM COATED in 1 BOTTLE (51407-165-28) 2024-01-24NoNoCurrent