FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
72789-193
11-digit product format
727890193
Labeler code
72789
Product ID
72789-193_2d6a1bfd-184b-822d-e063-6294a90a76ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076558
Marketing category
ANDA
Marketing start
2004-06-09
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
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 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
72789-193-06Ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET, FILM COATED630
72789-193-10Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1030
72789-193-12Ciprofloxacin12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1230
72789-193-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1430
72789-193-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-193-06EA - Each72789-193faaeab5a-2670-4761-8be5-99ec5984f9db12021-07-15
72789-193-10EA - Each72789-19311c6d918-870e-4d2f-97b6-0be73e074cce12021-11-09
72789-193-12EA - Each72789-1938d25edee-11d9-4e00-839c-ec34ffb44ab612022-01-06
72789-193-14EA - Each72789-193dc4c485d-4c14-47d2-8793-a1f274628e7912022-01-06
72789-193-20EA - Each72789-1936071a494-56fa-44fd-abe1-2e83cda1d5e012021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-193CIPROFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]30Current NDC, Legacy NDC, 5 package rows20250207_d275175c-691a-4d09-bbb7-50ee819e6727.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNd275175c-691a-4d09-bbb7-50ee819e672730
197511ciprofloxacin 250 MG Oral TabletSCDd275175c-691a-4d09-bbb7-50ee819e672730
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd275175c-691a-4d09-bbb7-50ee819e672730

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-193-06727890193066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-193-06) 2021-06-140000-00-00NoNoCurrent
72789-193-107278901931010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-193-10) 2022-12-220000-00-00NoNoCurrent
72789-193-127278901931212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-193-12) 2021-10-110000-00-00NoNoCurrent
72789-193-147278901931414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-193-14) 2021-11-110000-00-00NoNoCurrent
72789-193-207278901932020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-193-20) 2021-06-140000-00-00NoNoCurrent