FDA.reportPublic FDA data

ciprofloxacin

Product NDC
71335-0070
11-digit product format
713350070
Labeler code
71335
Product ID
71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0070-02024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-12024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-22024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-32024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-42024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-52024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-62024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-72024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-82024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-92024-05-17C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-02024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-12024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-22024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-32024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-42024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-52024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-62024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-72024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-82024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
71335-0070-92024-01-30C16284748780-11030e365-2000-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0070-0ciprofloxacin7 in 1 BOTTLETABLET710
71335-0070-1ciprofloxacin14 in 1 BOTTLETABLET1410
71335-0070-2ciprofloxacin30 in 1 BOTTLETABLET3010
71335-0070-3ciprofloxacin20 in 1 BOTTLETABLET2010
71335-0070-4ciprofloxacin60 in 1 BOTTLETABLET6010
71335-0070-5ciprofloxacin6 in 1 BOTTLETABLET610
71335-0070-6ciprofloxacin10 in 1 BOTTLETABLET1010
71335-0070-7ciprofloxacin28 in 1 BOTTLETABLET2810
71335-0070-8ciprofloxacin100 in 1 BOTTLETABLET10010
71335-0070-9ciprofloxacin40 in 1 BOTTLETABLET4010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0070-0EA - Each71335-0070b669770e-b1b7-4073-b733-2688234acb7812018-03-08
71335-0070-1EA - Each71335-007031c4ed6d-3a30-4750-9372-2ba5f282984012018-03-08
71335-0070-2EA - Each71335-0070e2e0965b-7f3e-4fd4-a12c-06aee03a994f12018-03-08
71335-0070-3EA - Each71335-0070d817fc6c-089d-4aa0-a0f5-bc2c9e1b5fce12018-03-08
71335-0070-4EA - Each71335-0070fae75aab-bcf6-494c-87dd-600bee2ebab412018-03-08
71335-0070-5EA - Each71335-0070138057fc-d0ea-4934-a039-0e9cecb649c812018-03-08
71335-0070-6EA - Each71335-007085927054-657b-4dc8-81f9-c774d98127c512018-03-08
71335-0070-7EA - Each71335-007061e8fe1a-ae1f-41f3-9749-9a09af6381e912018-03-08
71335-0070-8EA - Each71335-007078433a7d-2003-49f2-8051-8ffabbfa618612018-03-08
71335-0070-9EA - Each71335-0070fa29100c-b419-4fc8-8192-e0d26717794612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0070CIPROFLOXACIN TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20250331_a5ecc693-b8fd-4a7a-8040-e56f801c9353.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNa5ecc693-b8fd-4a7a-8040-e56f801c935310
309309ciprofloxacin 500 MG Oral TabletSCDa5ecc693-b8fd-4a7a-8040-e56f801c935310
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa5ecc693-b8fd-4a7a-8040-e56f801c935310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0070-0713350070007 TABLET in 1 BOTTLE (71335-0070-0) 7 tablet2022-06-280000-00-00NoNoCurrent
71335-0070-17133500700114 TABLET in 1 BOTTLE (71335-0070-1) 14 tablet2018-03-150000-00-00NoNoCurrent
71335-0070-27133500700230 TABLET in 1 BOTTLE (71335-0070-2) 30 tablet2018-03-200000-00-00NoNoCurrent
71335-0070-37133500700320 TABLET in 1 BOTTLE (71335-0070-3) 20 tablet2018-03-300000-00-00NoNoCurrent
71335-0070-47133500700460 TABLET in 1 BOTTLE (71335-0070-4) 60 tablet2019-08-080000-00-00NoNoCurrent
71335-0070-5713350070056 TABLET in 1 BOTTLE (71335-0070-5) 6 tablet2018-03-280000-00-00NoNoCurrent
71335-0070-67133500700610 TABLET in 1 BOTTLE (71335-0070-6) 10 tablet2018-02-280000-00-00NoNoCurrent
71335-0070-77133500700728 TABLET in 1 BOTTLE (71335-0070-7) 28 tablet2018-06-040000-00-00NoNoCurrent
71335-0070-871335007008100 TABLET in 1 BOTTLE (71335-0070-8) 100 tablet2018-05-040000-00-00NoNoCurrent
71335-0070-97133500700940 TABLET in 1 BOTTLE (71335-0070-9) 40 tablet2022-06-280000-00-00NoNoCurrent