FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-1867
11-digit product format
713351867
Labeler code
71335
Product ID
71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-1867-0Ciprofloxacin7 in 1 BOTTLETABLET, FILM COATED7108
71335-1867-1Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED20108
71335-1867-2Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED10108
71335-1867-3Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED14108
71335-1867-4Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED6108
71335-1867-5Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED30108
71335-1867-6Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED60108
71335-1867-7Ciprofloxacin12 in 1 BOTTLETABLET, FILM COATED12108
71335-1867-8Ciprofloxacin40 in 1 BOTTLETABLET, FILM COATED40108
71335-1867-9Ciprofloxacin90 in 1 BOTTLETABLET, FILM COATED90108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1867-1EA - Each71335-1867247bc9c9-23c8-4f9c-bbfa-d5a480945d3812021-11-09
71335-1867-2EA - Each71335-18672a48ef84-7268-42ad-98fa-78b9493f9b6712021-11-09
71335-1867-3EA - Each71335-186700ed7ba1-002e-43de-900f-0e5250f8d0f412021-11-09
71335-1867-4EA - Each71335-186752fd7a29-3727-4e47-8b5f-1dd464f9f37f12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1867CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 10 package rows20240929_4f600112-168a-4a58-9914-7c01f71894da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN4f600112-168a-4a58-9914-7c01f71894da108
197511ciprofloxacin 250 MG Oral TabletSCD4f600112-168a-4a58-9914-7c01f71894da108
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY4f600112-168a-4a58-9914-7c01f71894da108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1867-0713351867007 TABLET, FILM COATED in 1 BOTTLE (71335-1867-0) 2022-02-140000-00-00NoNoCurrent
71335-1867-17133518670120 TABLET, FILM COATED in 1 BOTTLE (71335-1867-1) 2021-05-100000-00-00NoNoCurrent
71335-1867-27133518670210 TABLET, FILM COATED in 1 BOTTLE (71335-1867-2) 2021-08-040000-00-00NoNoCurrent
71335-1867-37133518670314 TABLET, FILM COATED in 1 BOTTLE (71335-1867-3) 2021-07-120000-00-00NoNoCurrent
71335-1867-4713351867046 TABLET, FILM COATED in 1 BOTTLE (71335-1867-4) 2021-10-110000-00-00NoNoCurrent
71335-1867-57133518670530 TABLET, FILM COATED in 1 BOTTLE (71335-1867-5) 2022-02-140000-00-00NoNoCurrent
71335-1867-67133518670660 TABLET, FILM COATED in 1 BOTTLE (71335-1867-6) 2022-02-140000-00-00NoNoCurrent
71335-1867-77133518670712 TABLET, FILM COATED in 1 BOTTLE (71335-1867-7) 2022-02-140000-00-00NoNoCurrent
71335-1867-87133518670840 TABLET, FILM COATED in 1 BOTTLE (71335-1867-8) 2022-02-140000-00-00NoNoCurrent
71335-1867-97133518670990 TABLET, FILM COATED in 1 BOTTLE (71335-1867-9) 2022-02-140000-00-00NoNoCurrent