FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-2097
11-digit product format
713352097
Labeler code
71335
Product ID
71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208921
Marketing category
ANDA
Marketing start
2020-08-12
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
2027-12-31

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
71335-2097-0Ciprofloxacin7 in 1 BOTTLETABLET, COATED7103
71335-2097-1Ciprofloxacin20 in 1 BOTTLETABLET, COATED20103
71335-2097-2Ciprofloxacin10 in 1 BOTTLETABLET, COATED10103
71335-2097-3Ciprofloxacin14 in 1 BOTTLETABLET, COATED14103
71335-2097-4Ciprofloxacin6 in 1 BOTTLETABLET, COATED6103
71335-2097-5Ciprofloxacin30 in 1 BOTTLETABLET, COATED30103
71335-2097-6Ciprofloxacin60 in 1 BOTTLETABLET, COATED60103
71335-2097-7Ciprofloxacin12 in 1 BOTTLETABLET, COATED12103
71335-2097-8Ciprofloxacin40 in 1 BOTTLETABLET, COATED40103
71335-2097-9Ciprofloxacin90 in 1 BOTTLETABLET, COATED90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2097CIPROFLOXACIN TABLET, COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240420_5af16acc-51ce-41ed-b1c4-6b3fb38ef515.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN5af16acc-51ce-41ed-b1c4-6b3fb38ef515104
197511ciprofloxacin 250 MG Oral TabletSCD5af16acc-51ce-41ed-b1c4-6b3fb38ef515104
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY5af16acc-51ce-41ed-b1c4-6b3fb38ef515104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2097-0713352097007 TABLET, COATED in 1 BOTTLE (71335-2097-0) 2024-04-030000-00-00NoNoCurrent
71335-2097-17133520970120 TABLET, COATED in 1 BOTTLE (71335-2097-1) 2022-06-240000-00-00NoNoCurrent
71335-2097-27133520970210 TABLET, COATED in 1 BOTTLE (71335-2097-2) 2022-07-050000-00-00NoNoCurrent
71335-2097-37133520970314 TABLET, COATED in 1 BOTTLE (71335-2097-3) 2022-07-220000-00-00NoNoCurrent
71335-2097-4713352097046 TABLET, COATED in 1 BOTTLE (71335-2097-4) 2022-10-280000-00-00NoNoCurrent
71335-2097-57133520970530 TABLET, COATED in 1 BOTTLE (71335-2097-5) 2024-04-030000-00-00NoNoCurrent
71335-2097-67133520970660 TABLET, COATED in 1 BOTTLE (71335-2097-6) 2024-04-030000-00-00NoNoCurrent
71335-2097-77133520970712 TABLET, COATED in 1 BOTTLE (71335-2097-7) 2024-04-030000-00-00NoNoCurrent
71335-2097-87133520970840 TABLET, COATED in 1 BOTTLE (71335-2097-8) 2024-04-030000-00-00NoNoCurrent
71335-2097-97133520970990 TABLET, COATED in 1 BOTTLE (71335-2097-9) 2024-04-030000-00-00NoNoCurrent