FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
70518-4229
11-digit product format
705184229
Labeler code
70518
Product ID
70518-4229_495de50d-93b8-0884-e063-6294a90a9996
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208921
Marketing category
ANDA
Marketing start
2024-11-11
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
70518-4229-0Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET1410
70518-4229-1Ciprofloxacin20 in 1 BLISTER PACKTABLET2010
70518-4229-2Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET2010
70518-4229-3Ciprofloxacin30 in 1 BLISTER PACKTABLET3010
70518-4229-4Ciprofloxacin14 in 1 BLISTER PACKTABLET1410
70518-4229-5Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET1410
70518-4229-6Ciprofloxacin30 in 1 BLISTER PACKTABLET3010
70518-4229-7Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4229CIPROFLOXACIN (CIPROFOLXACIN) TABLET [REMEDYREPACK INC.]7Current NDC, 8 package rows20250523_c527d138-e32c-418f-9573-a3d8a796279f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNc527d138-e32c-418f-9573-a3d8a796279f10
309309ciprofloxacin 500 MG Oral TabletSCDc527d138-e32c-418f-9573-a3d8a796279f10
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYc527d138-e32c-418f-9573-a3d8a796279f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4229-07051842290014 TABLET in 1 BOTTLE, PLASTIC (70518-4229-0) 14 tablet2024-11-11NoNoCurrent
70518-4229-17051842290120 TABLET in 1 BLISTER PACK (70518-4229-1) 20 tablet2024-12-11NoNoCurrent
70518-4229-27051842290220 TABLET in 1 BOTTLE, PLASTIC (70518-4229-2) 20 tablet2025-01-14NoNoCurrent
70518-4229-37051842290330 TABLET in 1 BLISTER PACK (70518-4229-3) 30 tablet2025-01-29NoNoCurrent
70518-4229-47051842290414 TABLET in 1 BLISTER PACK (70518-4229-4) 14 tablet2025-05-19NoNoCurrent
70518-4229-57051842290514 TABLET in 1 BOTTLE, PLASTIC (70518-4229-5) 14 tablet2025-07-09NoNoCurrent
70518-4229-67051842290630 TABLET in 1 BLISTER PACK (70518-4229-6) 30 tablet2025-07-31NoNoCurrent
70518-4229-77051842290730 TABLET in 1 BOTTLE, PLASTIC (70518-4229-7) 30 tablet2026-01-26NoNoCurrent