FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
71335-1152
11-digit product format
713351152
Labeler code
71335
Product ID
71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208921
Marketing category
ANDA
Marketing start
2019-07-13
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1152-02024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-12024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-22024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-32024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-42024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-52024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-62024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-72024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-82024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-92024-05-17C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-02024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-12024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-22024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-32024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-42024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-52024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-62024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-72024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-82024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
71335-1152-92024-01-30C16284748780-11030e365-580f-111a-e063-dadaa90a10e2Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1152-0Ciprofloxacin7 in 1 BOTTLETABLET, COATED78
71335-1152-1Ciprofloxacin20 in 1 BOTTLETABLET, COATED208
71335-1152-2Ciprofloxacin10 in 1 BOTTLETABLET, COATED108
71335-1152-3Ciprofloxacin14 in 1 BOTTLETABLET, COATED148
71335-1152-4Ciprofloxacin6 in 1 BOTTLETABLET, COATED68
71335-1152-5Ciprofloxacin30 in 1 BOTTLETABLET, COATED308
71335-1152-6Ciprofloxacin60 in 1 BOTTLETABLET, COATED608
71335-1152-7Ciprofloxacin12 in 1 BOTTLETABLET, COATED128
71335-1152-8Ciprofloxacin40 in 1 BOTTLETABLET, COATED408
71335-1152-9Ciprofloxacin90 in 1 BOTTLETABLET, COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1152CIPROFLOXACIN (CIPROFLOXACIN TABLETS) TABLET, COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20250224_8d6ec3ee-2205-4d78-bc48-d39f371797c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN8d6ec3ee-2205-4d78-bc48-d39f371797c18
197511ciprofloxacin 250 MG Oral TabletSCD8d6ec3ee-2205-4d78-bc48-d39f371797c18
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY8d6ec3ee-2205-4d78-bc48-d39f371797c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1152-0713351152007 TABLET, COATED in 1 BOTTLE (71335-1152-0) 2025-01-290000-00-00NoNoCurrent
71335-1152-17133511520120 TABLET, COATED in 1 BOTTLE (71335-1152-1) 2025-01-290000-00-00NoNoCurrent
71335-1152-27133511520210 TABLET, COATED in 1 BOTTLE (71335-1152-2) 2025-01-290000-00-00NoNoCurrent
71335-1152-37133511520314 TABLET, COATED in 1 BOTTLE (71335-1152-3) 2025-01-290000-00-00NoNoCurrent
71335-1152-4713351152046 TABLET, COATED in 1 BOTTLE (71335-1152-4) 2025-01-290000-00-00NoNoCurrent
71335-1152-57133511520530 TABLET, COATED in 1 BOTTLE (71335-1152-5) 2025-01-290000-00-00NoNoCurrent
71335-1152-67133511520660 TABLET, COATED in 1 BOTTLE (71335-1152-6) 2025-01-290000-00-00NoNoCurrent
71335-1152-77133511520712 TABLET, COATED in 1 BOTTLE (71335-1152-7) 2025-01-290000-00-00NoNoCurrent
71335-1152-87133511520840 TABLET, COATED in 1 BOTTLE (71335-1152-8) 2025-01-290000-00-00NoNoCurrent
71335-1152-97133511520990 TABLET, COATED in 1 BOTTLE (71335-1152-9) 2025-01-290000-00-00NoNoCurrent