FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
72789-519
11-digit product format
727890519
Labeler code
72789
Product ID
72789-519_3f92e4b4-bd66-8f5d-e063-6394a90aa46d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA208921
Marketing category
ANDA
Marketing start
2023-10-01
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
72789-519-06Ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET68
72789-519-10Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET108
72789-519-12Ciprofloxacin12 in 1 BOTTLE, PLASTICTABLET128
72789-519-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET148
72789-519-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-519-06EA - Each72789-519140d9087-c07d-4db0-99cb-08f003b9769812025-10-14
72789-519-10EA - Each72789-51908738a86-a643-43ef-935c-88aaadf46fd612025-09-12
72789-519-12EA - Each72789-519e014ccf8-7014-466b-8c68-4c34b02c057712025-11-13
72789-519-14EA - Each72789-5198b0bb231-0216-4828-aaf5-c16cdbb7e54c12025-09-12
72789-519-20EA - Each72789-51934f66343-787c-4bbc-a3e0-8bc63d579baa12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN3b3c0874-90b7-deda-e063-6394a90a78028
197511ciprofloxacin 250 MG Oral TabletSCD3b3c0874-90b7-deda-e063-6394a90a78028
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY3b3c0874-90b7-deda-e063-6394a90a78028

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-519-06727890519066 TABLET in 1 BOTTLE, PLASTIC (72789-519-06) 6 tablet2025-09-18NoNoHistorical
72789-519-107278905191010 TABLET in 1 BOTTLE, PLASTIC (72789-519-10) 10 tablet2025-08-22NoNoHistorical
72789-519-127278905191212 TABLET in 1 BOTTLE, PLASTIC (72789-519-12) 12 tablet2025-10-24NoNoHistorical
72789-519-147278905191414 TABLET in 1 BOTTLE, PLASTIC (72789-519-14) 14 tablet2025-07-31NoNoHistorical
72789-519-207278905192020 TABLET in 1 BOTTLE, PLASTIC (72789-519-20) 20 tablet2025-09-10NoNoHistorical