FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
68788-8692
11-digit product format
687888692
Labeler code
68788
Product ID
68788-8692_0967063c-d31b-41d5-90ec-aefd12e7a327
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofolxacin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208921
Marketing category
ANDA
Marketing start
2024-06-10
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 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 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
68788-8692-0Ciprofloxacin6 in 1 BOTTLETABLET63
68788-8692-1Ciprofloxacin14 in 1 BOTTLETABLET143
68788-8692-2Ciprofloxacin20 in 1 BOTTLETABLET203
68788-8692-3Ciprofloxacin30 in 1 BOTTLETABLET303
68788-8692-8Ciprofloxacin10 in 1 BOTTLETABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8692-0EA - Each68788-8692a2f6a17f-ec2e-4a90-8e95-d592139ae63912024-08-12
68788-8692-1EA - Each68788-86921c25059e-4e24-4ba1-9098-de5399708f6112024-08-12
68788-8692-2EA - Each68788-869207587ff0-5116-4621-a1ec-3a42b055850612024-08-12
68788-8692-3EA - Each68788-86926d1f0504-a02f-4840-9a1a-0346e1a1f38d12024-08-12
68788-8692-8EA - Each68788-8692500c33ba-eec4-48b2-a4fb-eac55de9130a12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8692CIPROFLOXACIN (CIPROFOLXACIN) TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250305_4425d454-210d-4b9f-88ad-6b32a9e0d3bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN4425d454-210d-4b9f-88ad-6b32a9e0d3bd3
309309ciprofloxacin 500 MG Oral TabletSCD4425d454-210d-4b9f-88ad-6b32a9e0d3bd3
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4425d454-210d-4b9f-88ad-6b32a9e0d3bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8692-0687888692006 TABLET in 1 BOTTLE (68788-8692-0) 6 tablet2024-06-10NoNoHistorical
68788-8692-16878886920114 TABLET in 1 BOTTLE (68788-8692-1) 14 tablet2024-06-10NoNoHistorical
68788-8692-26878886920220 TABLET in 1 BOTTLE (68788-8692-2) 20 tablet2024-06-10NoNoHistorical
68788-8692-36878886920330 TABLET in 1 BOTTLE (68788-8692-3) 30 tablet2024-06-10NoNoHistorical
68788-8692-86878886920810 TABLET in 1 BOTTLE (68788-8692-8) 10 tablet2024-06-10NoNoHistorical