ciprofloxacin

Product NDC
33261-367
11-digit product format
332610367
Labeler code
33261
Product ID
33261-367_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
750 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
33261-367-202020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg
33261-367-302020-01-31C16284748780-19d75b9d1-24d5-f424-e053-dadaa90a57ceCiprofloxacin Tablets 250 mg, 500 mg and 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-367-20ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET203
33261-367-30ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-367-20EA - Each33261-36723517493-e858-4072-9b1c-517c0961d33912015-10-02
33261-367-30EA - Each33261-3676731624d-ccfe-4961-a849-f45352ec5f2e12015-10-02

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
33261-367CIPROFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 2 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
33261-367-203326103672020 in 1 BOTTLE, PLASTICHistorical
33261-367-303326103673030 in 1 BOTTLE, PLASTICHistorical