FDA.reportPublic FDA data

ciprofloxacin

Product NDC
63187-017
11-digit product format
631870017
Labeler code
63187
Product ID
63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [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
63187-017-06ciprofloxacin6 in 1 BOTTLETABLET614
63187-017-10ciprofloxacin10 in 1 BOTTLETABLET1014
63187-017-14ciprofloxacin14 in 1 BOTTLETABLET1414
63187-017-20ciprofloxacin20 in 1 BOTTLETABLET2014
63187-017-28ciprofloxacin28 in 1 BOTTLETABLET2814
63187-017-30ciprofloxacin30 in 1 BOTTLETABLET3014
63187-017-60ciprofloxacin60 in 1 BOTTLETABLET6014
63187-017-90ciprofloxacin90 in 1 BOTTLETABLET9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-017CIPROFLOXACIN TABLET [PROFICIENT RX LP]14Current NDC, Legacy NDC, 8 package rows20220609_fbcd32c0-bcfd-4cc7-8e81-6612bc0cfc45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
309309ciprofloxacin 500 MG Oral TabletPSNfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
197511ciprofloxacin 250 MG Oral TabletSCDfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
309309ciprofloxacin 500 MG Oral TabletSCDfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc4514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-017-06631870017066 TABLET in 1 BOTTLE (63187-017-06) 6 tablet2014-08-010000-00-00NoNoCurrent
63187-017-106318700171010 TABLET in 1 BOTTLE (63187-017-10) 10 tablet2014-08-010000-00-00NoNoCurrent
63187-017-146318700171414 TABLET in 1 BOTTLE (63187-017-14) 14 tablet2014-08-010000-00-00NoNoCurrent
63187-017-206318700172020 TABLET in 1 BOTTLE (63187-017-20) 20 tablet2014-08-010000-00-00NoNoCurrent
63187-017-286318700172828 TABLET in 1 BOTTLE (63187-017-28) 28 tablet2016-08-040000-00-00NoNoCurrent
63187-017-306318700173030 TABLET in 1 BOTTLE (63187-017-30) 30 tablet2014-08-010000-00-00NoNoCurrent
63187-017-606318700176060 TABLET in 1 BOTTLE (63187-017-60) 60 tablet2021-07-230000-00-00NoNoCurrent
63187-017-906318700179090 TABLET in 1 BOTTLE (63187-017-90) 90 tablet2021-07-230000-00-00NoNoCurrent