FDA.reportPublic FDA data

ciprofloxacin

Product NDC
43063-869
11-digit product format
430630869
Labeler code
43063
Product ID
43063-869_36c1922f-56d3-9a55-e063-6294a90a5571
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx 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
43063-869-06ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET620
43063-869-08ciprofloxacin8 in 1 BOTTLE, PLASTICTABLET820
43063-869-10ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET1020
43063-869-20ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET2020
43063-869-30ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET3020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-869CIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 5 package rows20250315_e81341c6-0e25-4860-adda-2d3cebe88d62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNe81341c6-0e25-4860-adda-2d3cebe88d6220
309309ciprofloxacin 500 MG Oral TabletSCDe81341c6-0e25-4860-adda-2d3cebe88d6220
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYe81341c6-0e25-4860-adda-2d3cebe88d6220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-869-06430630869066 TABLET in 1 BOTTLE, PLASTIC (43063-869-06) 6 tablet2018-08-040000-00-00NoNoCurrent
43063-869-08430630869088 TABLET in 1 BOTTLE, PLASTIC (43063-869-08) 8 tablet2018-07-110000-00-00NoNoCurrent
43063-869-104306308691010 TABLET in 1 BOTTLE, PLASTIC (43063-869-10) 10 tablet2018-08-220000-00-00NoNoCurrent
43063-869-204306308692020 TABLET in 1 BOTTLE, PLASTIC (43063-869-20) 20 tablet2018-08-170000-00-00NoNoCurrent
43063-869-304306308693030 TABLET in 1 BOTTLE, PLASTIC (43063-869-30) 30 tablet2018-08-170000-00-00NoNoCurrent