Ciprofloxacin

Product NDC
21695-210
11-digit product format
216950210
Labeler code
21695
Product ID
21695-210_b5e00846-c681-472a-a8eb-78215e6d8a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA076794
Marketing category
ANDA
Marketing start
2004-06-09
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-210-06Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED61
21695-210-10Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED101
21695-210-14Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED141
21695-210-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED201
21695-210-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-210-06EA - Each21695-2107360f68a-d784-4b89-a809-eb2d702c9ab612012-07-24
21695-210-10EA - Each21695-210167c5122-4430-463d-836c-d3995c8ed78912012-07-24
21695-210-14EA - Each21695-210c8b3d554-4ab2-4ab0-85ee-af670ef0ac7812012-07-24
21695-210-20EA - Each21695-210c4728f64-6f7d-4311-b943-2132ea65d84212012-07-24
21695-210-30EA - Each21695-210435255ca-3cc8-40a4-917f-3e880c1ac7cc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
crospovidoneINACTIVE INGREDIENT68401960MKCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-210CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 5 package rows20100212_b57529e5-c106-464e-8637-dc02871031f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNb57529e5-c106-464e-8637-dc02871031f71
309309ciprofloxacin 500 MG Oral TabletSCDb57529e5-c106-464e-8637-dc02871031f71
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb57529e5-c106-464e-8637-dc02871031f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-210-06216950210066 in 1 BOTTLEHistorical
21695-210-102169502101010 in 1 BOTTLEHistorical
21695-210-142169502101414 in 1 BOTTLEHistorical
21695-210-202169502102020 in 1 BOTTLEHistorical
21695-210-302169502103030 in 1 BOTTLEHistorical