FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
70518-4133
11-digit product format
705184133
Labeler code
70518
Product ID
70518-4133_5035e76f-2c34-c0df-e063-6394a90a2b7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208921
Marketing category
ANDA
Marketing start
2024-07-03
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 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 HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511

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
70518-4133-0Ciprofloxacin30 in 1 BLISTER PACKTABLET305
70518-4133-1Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET105
70518-4133-2Ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET65
70518-4133-3Ciprofloxacin50 in 1 BOXTABLET505
70518-4133-4Ciprofloxacin1 in 1 POUCHTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4133CIPROFLOXACIN (CIPROFOLXACIN) TABLET [REMEDYREPACK INC.]2Current NDC, 5 package rows20241010_4edc4fda-7834-46cc-a0ed-22f117e6e10b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN4edc4fda-7834-46cc-a0ed-22f117e6e10b5
197511ciprofloxacin 250 MG Oral TabletSCD4edc4fda-7834-46cc-a0ed-22f117e6e10b5
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY4edc4fda-7834-46cc-a0ed-22f117e6e10b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4133-07051841330030 TABLET in 1 BLISTER PACK (70518-4133-0) 30 tablet2024-07-03NoNoHistorical
70518-4133-17051841330110 TABLET in 1 BOTTLE, PLASTIC (70518-4133-1) 10 tablet2024-10-06NoNoHistorical
70518-4133-2705184133026 TABLET in 1 BOTTLE, PLASTIC (70518-4133-2) 6 tablet2026-04-13NoNoHistorical
70518-4133-37051841330350 POUCH in 1 BOX (70518-4133-3) / 1 TABLET in 1 POUCH (70518-4133-4) 50 pouch2026-04-24NoNoHistorical
70518-4133-4705184133041 in 1 POUCHHistorical