Ciprofloxacin

Product NDC
82982-050
11-digit product format
829820050
Labeler code
82982
Product ID
82982-050_198d06e8-115c-8ac3-e063-6394a90a978e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharmasource Meds, LLC
Application
ANDA077859
Marketing category
ANDA
Marketing start
2023-01-23
Marketing end
2026-07-31
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
82982-050-14Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED143
82982-050-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82982-050CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHARMASOURCE MEDS, LLC]3Current NDC, 2 package rows20240602_f2937a87-2e10-3728-e053-2a95a90a9eb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNf2937a87-2e10-3728-e053-2a95a90a9eb93
309309ciprofloxacin 500 MG Oral TabletSCDf2937a87-2e10-3728-e053-2a95a90a9eb93
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYf2937a87-2e10-3728-e053-2a95a90a9eb93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82982-050-148298200501414 TABLET, FILM COATED in 1 BOTTLE (82982-050-14) 2023-01-232026-07-31NoNoHistorical
82982-050-208298200502020 in 1 BOTTLEHistorical