FDA.reportPublic FDA data

CIPROFLOXACIN

Product NDC
72189-111
11-digit product format
721890111
Labeler code
72189
Product ID
72189-111_4c499af5-b74b-2799-e063-6294a90a7054
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077859
Marketing category
ANDA
Marketing start
2020-06-12
Marketing end
2027-02-28
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CIPROFLOXACIN

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
72189-111-10CIPROFLOXACIN10 in 1 BOTTLETABLET, FILM COATED107
72189-111-14CIPROFLOXACIN14 in 1 BOTTLETABLET, FILM COATED147
72189-111-20CIPROFLOXACIN20 in 1 BOTTLETABLET, FILM COATED207
72189-111-30CIPROFLOXACIN30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-111-14EA - Each72189-1118c340f3f-aee2-47d7-b5bd-c7cbb789858312020-07-13
72189-111-30EA - Each72189-111682d061b-0ba8-4d85-be3b-5ed084c0dafc12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-111CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [DIRECT RX]6Current NDC, Legacy NDC, 4 package rows20250119_a7e5174a-dd01-6050-e053-2a95a90add3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNa7e5174a-dd01-6050-e053-2a95a90add3f7
309309ciprofloxacin 500 MG Oral TabletSCDa7e5174a-dd01-6050-e053-2a95a90add3f7
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa7e5174a-dd01-6050-e053-2a95a90add3f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-111-107218901111010 TABLET, FILM COATED in 1 BOTTLE (72189-111-10) 2020-06-122027-02-28NoNoHistorical
72189-111-147218901111414 TABLET, FILM COATED in 1 BOTTLE (72189-111-14) 2020-06-122027-02-28NoNoCurrent
72189-111-207218901112020 TABLET, FILM COATED in 1 BOTTLE (72189-111-20) 2020-06-122027-02-28NoNoCurrent
72189-111-307218901113030 TABLET, FILM COATED in 1 BOTTLE (72189-111-30) 2020-06-122027-02-28NoNoCurrent