FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68788-8875
11-digit product format
687888875
Labeler code
68788
Product ID
68788-8875_15755a35-e29a-47c1-89ab-e6645bb3ade9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208921
Marketing category
ANDA
Marketing start
2025-05-19
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
68788-8875-0Ciprofloxacin6 in 1 BOTTLETABLET61
68788-8875-1Ciprofloxacin14 in 1 BOTTLETABLET141
68788-8875-2Ciprofloxacin20 in 1 BOTTLETABLET201
68788-8875-3Ciprofloxacin30 in 1 BOTTLETABLET301
68788-8875-4Ciprofloxacin40 in 1 BOTTLETABLET401
68788-8875-6Ciprofloxacin60 in 1 BOTTLETABLET601
68788-8875-8Ciprofloxacin10 in 1 BOTTLETABLET101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8875-0EA - Each68788-8875d6ab1154-d726-4478-9000-01b1537a7f4a12025-07-08
68788-8875-1EA - Each68788-8875b9866f84-372e-4730-8812-d9850d55bc5212025-07-08
68788-8875-2EA - Each68788-8875411edfcb-5e1b-4490-8e3d-a36dc1b2488012025-07-08
68788-8875-3EA - Each68788-887505c29389-d975-4827-9dc8-312b2a46425c12025-07-08
68788-8875-4EA - Each68788-88758510b140-1f3c-4cba-9f1b-2685da61422612025-07-08
68788-8875-6EA - Each68788-887542edb0c0-b2ec-4e3e-b363-bfbd658a987012025-07-08
68788-8875-8EA - Each68788-8875e27a6ff5-a8de-4b49-aa1b-a9814a3122b312025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8875CIPROFLOXACIN (CIPROFOLXACIN) TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 7 package rows20250521_15755a35-e29a-47c1-89ab-e6645bb3ade9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN15755a35-e29a-47c1-89ab-e6645bb3ade91
197511ciprofloxacin 250 MG Oral TabletSCD15755a35-e29a-47c1-89ab-e6645bb3ade91
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY15755a35-e29a-47c1-89ab-e6645bb3ade91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8875-0687888875006 TABLET in 1 BOTTLE (68788-8875-0) 6 tablet2025-05-19NoNoHistorical
68788-8875-16878888750114 TABLET in 1 BOTTLE (68788-8875-1) 14 tablet2025-05-19NoNoHistorical
68788-8875-26878888750220 TABLET in 1 BOTTLE (68788-8875-2) 20 tablet2025-05-19NoNoHistorical
68788-8875-36878888750330 TABLET in 1 BOTTLE (68788-8875-3) 30 tablet2025-05-19NoNoHistorical
68788-8875-46878888750440 TABLET in 1 BOTTLE (68788-8875-4) 40 tablet2025-05-19NoNoHistorical
68788-8875-66878888750660 TABLET in 1 BOTTLE (68788-8875-6) 60 tablet2025-05-19NoNoHistorical
68788-8875-86878888750810 TABLET in 1 BOTTLE (68788-8875-8) 10 tablet2025-05-19NoNoHistorical