FDA.reportPublic FDA data

ciprofloxacin

Product NDC
66267-919
11-digit product format
662670919
Labeler code
66267
Product ID
66267-919_1fa773d7-02b2-11c3-e063-6394a90ac730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
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
66267-919-06ciprofloxacin6 in 1 BOTTLETABLET64
66267-919-10ciprofloxacin10 in 1 BOTTLETABLET104
66267-919-21ciprofloxacin21 in 1 BOTTLETABLET214
66267-919-30ciprofloxacin30 in 1 BOTTLETABLET304
66267-919-60ciprofloxacin60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-919-06EA - Each66267-919fa8ef7f5-e290-43c7-9284-370dab3d775412017-03-06
66267-919-10EA - Each66267-91998757901-352e-4392-943e-5f751caaf4fc12017-03-06
66267-919-30EA - Each66267-919de15b072-3b93-4695-b429-8282fa1bdae612017-03-06
66267-919-60EA - Each66267-91924b191d1-784d-4e13-9aed-69dc05152d0412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-919CIPROFLOXACIN TABLET [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 5 package rows20240816_46dedf2c-26de-0f46-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN46dedf2c-26de-0f46-e054-00144ff88e884
309309ciprofloxacin 500 MG Oral TabletSCD46dedf2c-26de-0f46-e054-00144ff88e884
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY46dedf2c-26de-0f46-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-919-06662670919066 TABLET in 1 BOTTLE (66267-919-06) 6 tablet2017-01-240000-00-00NoNoCurrent
66267-919-106626709191010 TABLET in 1 BOTTLE (66267-919-10) 10 tablet2017-01-240000-00-00NoNoCurrent
66267-919-216626709192121 TABLET in 1 BOTTLE (66267-919-21) 21 tablet2017-01-240000-00-00NoNoCurrent
66267-919-306626709193030 TABLET in 1 BOTTLE (66267-919-30) 30 tablet2017-01-240000-00-00NoNoCurrent
66267-919-606626709196060 TABLET in 1 BOTTLE (66267-919-60) 60 tablet2017-01-240000-00-00NoNoCurrent