Ciprofloxacin
Ciprofloxacin-Mylan
Approved
Approval ID
a974ef05-1cc3-4cbc-a0b4-36b46ed107c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2011
Manufacturers
FDA
Legacy Pharmaceutical Packaging
DUNS: 143213275
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ciprofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68645-060
Application NumberANDA075817
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciprofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2011
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT