FDA.reportPublic FDA data

ciprofloxacin

Product NDC
33261-164
11-digit product format
332610164
Labeler code
33261
Product ID
33261-164_da202d5d-414e-42a2-8a90-e20c90b0afec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
33261-164-062020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-072020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-102020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-132020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-142020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-202020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-242020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-282020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-302020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-422020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-164-602020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-164-06ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET63
33261-164-07ciprofloxacin7 in 1 BOTTLE, PLASTICTABLET73
33261-164-10ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET103
33261-164-13ciprofloxacin4 in 1 BOTTLE, PLASTICTABLET43
33261-164-14ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET143
33261-164-20ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET203
33261-164-24ciprofloxacin24 in 1 BOTTLE, PLASTICTABLET243
33261-164-28ciprofloxacin28 in 1 BOTTLE, PLASTICTABLET283
33261-164-30ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET303
33261-164-42ciprofloxacin42 in 1 BOTTLE, PLASTICTABLET423
33261-164-60ciprofloxacin60 in 1 BOTTLE, PLASTICTABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-164-06EA - Each33261-164c43b317c-8562-425b-af3c-964c42ac0a0112015-10-02
33261-164-07EA - Each33261-164b8f111bc-a736-4e67-8e73-504a4feb2a9012015-10-02
33261-164-10EA - Each33261-1641344b660-60ca-467e-b878-37246dc6852012015-10-02
33261-164-13EA - Each33261-164441bfdee-0755-4319-bb7e-7740433cf00212016-09-02
33261-164-14EA - Each33261-1640534edf3-63ee-4ae9-a926-4eb7eee8971e12015-10-02
33261-164-20EA - Each33261-164df6b09bb-443f-4d8e-93b7-a82a6dd1c5f112015-10-02
33261-164-24EA - Each33261-164599de759-2447-4de9-b0de-37d5769a52f112016-09-02
33261-164-28EA - Each33261-16478911736-e3fc-4b96-b17f-d100ab4e5cd312015-10-02
33261-164-30EA - Each33261-164125d6d8d-6613-4a64-9122-eb39c287a64312015-10-02
33261-164-42EA - Each33261-1642349c941-2c21-4dcc-8045-23b63b40e93012016-09-02
33261-164-60EA - Each33261-1644c10d062-919d-47fb-b485-abb057a07a2d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-164CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 11 package rows20140102_d10f7c93-a08b-4e9c-bfa2-6646e3ea21bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
309309ciprofloxacin 500 MG Oral TabletPSNd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197512ciprofloxacin 750 MG Oral TabletPSNd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197511ciprofloxacin 250 MG Oral TabletSCDd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
309309ciprofloxacin 500 MG Oral TabletSCDd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197512ciprofloxacin 750 MG Oral TabletSCDd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSYd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd10f7c93-a08b-4e9c-bfa2-6646e3ea21bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-164-06332610164066 in 1 BOTTLE, PLASTICHistorical
33261-164-07332610164077 in 1 BOTTLE, PLASTICHistorical
33261-164-103326101641010 in 1 BOTTLE, PLASTICHistorical
33261-164-13332610164134 in 1 BOTTLE, PLASTICHistorical
33261-164-143326101641414 in 1 BOTTLE, PLASTICHistorical
33261-164-203326101642020 in 1 BOTTLE, PLASTICHistorical
33261-164-243326101642424 in 1 BOTTLE, PLASTICHistorical
33261-164-283326101642828 in 1 BOTTLE, PLASTICHistorical
33261-164-303326101643030 in 1 BOTTLE, PLASTICHistorical
33261-164-423326101644242 in 1 BOTTLE, PLASTICHistorical
33261-164-603326101646060 in 1 BOTTLE, PLASTICHistorical