FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
70518-3063
11-digit product format
705183063
Labeler code
70518
Product ID
70518-3063_4e90dbf6-0991-5bab-e063-6394a90aacf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076558
Marketing category
ANDA
Marketing start
2021-04-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin
Listing expiration
2027-12-31

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
70518-3063-0Ciprofloxacin30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-3063-1Ciprofloxacin14 in 1 BLISTER PACKTABLET, FILM COATED1414
70518-3063-2Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2014
70518-3063-3Ciprofloxacin20 in 1 BLISTER PACKTABLET, FILM COATED2014
70518-3063-4Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1414
70518-3063-5Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1014
70518-3063-6Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3063CIPROFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 7 package rows20240926_44b6cefc-7638-4437-95e7-8f239f66a9d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN44b6cefc-7638-4437-95e7-8f239f66a9d414
309309ciprofloxacin 500 MG Oral TabletSCD44b6cefc-7638-4437-95e7-8f239f66a9d414
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY44b6cefc-7638-4437-95e7-8f239f66a9d414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3063-07051830630030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3063-0) 2021-04-020000-00-00NoNoCurrent
70518-3063-17051830630114 TABLET, FILM COATED in 1 BLISTER PACK (70518-3063-1) 2021-04-280000-00-00NoNoCurrent
70518-3063-27051830630220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-2) 2021-05-240000-00-00NoNoCurrent
70518-3063-37051830630320 TABLET, FILM COATED in 1 BLISTER PACK (70518-3063-3) 2021-06-040000-00-00NoNoCurrent
70518-3063-47051830630414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-4) 2021-07-210000-00-00NoNoCurrent
70518-3063-57051830630510 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-5) 2022-05-090000-00-00NoNoCurrent
70518-3063-67051830630630 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3063-6) 2022-08-040000-00-00NoNoCurrent