Ciprofloxacin
CIPROFLOXACIN TABLETS, USP
Approved
Approval ID
42c00a53-66db-4c8b-b5db-ccb9d02e5344
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2012
Manufacturers
FDA
HHS/Program Support Center/Supply Service Center
DUNS: 194032918
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ciprofloxacin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11819-323
Application NumberANDA076794
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciprofloxacin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (10)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ciprofloxacin hydrochlorideActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT