FDA.reportPublic FDA data

ciprofloxacin

Product NDC
33261-399
11-digit product format
332610399
Labeler code
33261
Product ID
33261-399_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
250 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
33261-399-062020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-399-102020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-399-142020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-399-202020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-399-212020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-399-302020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-399-06ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET63
33261-399-10ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET103
33261-399-14ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET143
33261-399-20ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET203
33261-399-21ciprofloxacin21 in 1 BOTTLE, PLASTICTABLET213
33261-399-30ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-399-06EA - Each33261-3999ca5311c-c742-4103-9d27-833da4181bce12015-10-02
33261-399-10EA - Each33261-399877d44ac-be31-4a25-90a9-e1e638b85a1012015-10-02
33261-399-14EA - Each33261-3990193678b-1c9d-4f40-943f-185ef890c2f412015-10-02
33261-399-20EA - Each33261-399c231e7f5-667c-4704-ba05-eef8b3c9afd712015-10-02
33261-399-21EA - Each33261-39900a65da0-20ab-4b71-902c-99dd4f12c9e112016-09-02
33261-399-30EA - Each33261-3991811b485-1b72-47cc-99e8-f2188a148d1a12015-10-02

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
33261-399CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 6 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
33261-399-06332610399066 in 1 BOTTLE, PLASTICHistorical
33261-399-103326103991010 in 1 BOTTLE, PLASTICHistorical
33261-399-143326103991414 in 1 BOTTLE, PLASTICHistorical
33261-399-203326103992020 in 1 BOTTLE, PLASTICHistorical
33261-399-213326103992121 in 1 BOTTLE, PLASTICHistorical
33261-399-303326103993030 in 1 BOTTLE, PLASTICHistorical