FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-1347
11-digit product format
713351347
Labeler code
71335
Product ID
71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076126
Marketing category
ANDA
Marketing start
2009-10-10
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
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 HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511, 309309

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
71335-1347-0Ciprofloxacin7 in 1 BOTTLETABLET, FILM COATED76
71335-1347-1Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED146
71335-1347-2Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED306
71335-1347-3Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED206
71335-1347-4Ciprofloxacin60 in 1 BOTTLETABLET, FILM COATED606
71335-1347-5Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED66
71335-1347-6Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED106
71335-1347-7Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED286
71335-1347-8Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1006
71335-1347-9Ciprofloxacin40 in 1 BOTTLETABLET, FILM COATED406

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1347-3EA - Each71335-1347297768e1-3599-47de-bf89-03240662594312020-09-14
71335-1347-4EA - Each71335-134729bf4ce8-51b5-4b4b-9531-65f206669a3012020-09-14
71335-1347-6EA - Each71335-1347d0c92399-cabd-4d65-9877-afa7da363ef412020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1347CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20241027_b283d662-9be1-49c7-be03-cb21055314c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin 500 MG Oral TabletPSNb283d662-9be1-49c7-be03-cb21055314c16
197511ciprofloxacin 250 MG Oral TabletSCDb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin 500 MG Oral TabletSCDb283d662-9be1-49c7-be03-cb21055314c16
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb283d662-9be1-49c7-be03-cb21055314c16
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYb283d662-9be1-49c7-be03-cb21055314c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1347-0713351347007 TABLET, FILM COATED in 1 BOTTLE (71335-1347-0) 2024-05-300000-00-00NoNoCurrent
71335-1347-17133513470114 TABLET, FILM COATED in 1 BOTTLE (71335-1347-1) 2024-05-300000-00-00NoNoCurrent
71335-1347-27133513470230 TABLET, FILM COATED in 1 BOTTLE (71335-1347-2) 2024-05-300000-00-00NoNoCurrent
71335-1347-37133513470320 TABLET, FILM COATED in 1 BOTTLE (71335-1347-3) 2024-05-300000-00-00NoNoCurrent
71335-1347-47133513470460 TABLET, FILM COATED in 1 BOTTLE (71335-1347-4) 2024-05-300000-00-00NoNoCurrent
71335-1347-5713351347056 TABLET, FILM COATED in 1 BOTTLE (71335-1347-5) 2024-05-300000-00-00NoNoCurrent
71335-1347-67133513470610 TABLET, FILM COATED in 1 BOTTLE (71335-1347-6) 2024-05-300000-00-00NoNoCurrent
71335-1347-77133513470728 TABLET, FILM COATED in 1 BOTTLE (71335-1347-7) 2024-05-300000-00-00NoNoCurrent
71335-1347-871335134708100 TABLET, FILM COATED in 1 BOTTLE (71335-1347-8) 2024-05-300000-00-00NoNoCurrent
71335-1347-97133513470940 TABLET, FILM COATED in 1 BOTTLE (71335-1347-9) 2024-05-300000-00-00NoNoCurrent