FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
72789-511
11-digit product format
727890511
Labeler code
72789
Product ID
72789-511_3ea0f42a-4723-5f6f-e063-6394a90a95d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077859
Marketing category
ANDA
Marketing start
2024-02-09
Marketing end
2028-02-29
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
72789-511-10Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED107
72789-511-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED147
72789-511-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED207
72789-511-30Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNa914512b-9a4a-4c53-ab7a-2e2b1ea8a0127
309309ciprofloxacin 500 MG Oral TabletSCDa914512b-9a4a-4c53-ab7a-2e2b1ea8a0127
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa914512b-9a4a-4c53-ab7a-2e2b1ea8a0127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-511-107278905111010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-10) 2025-08-272028-02-29NoNoHistorical
72789-511-147278905111414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-14) 2025-07-312028-02-29NoNoHistorical
72789-511-207278905112020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-20) 2025-09-122028-02-29NoNoHistorical
72789-511-307278905113030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-30) 2025-06-022028-02-29NoNoHistorical