Ciprofloxacin
Ciprofloxacin Tablets, USP
Approved
Approval ID
c4022360-6081-451e-806e-4632a05c6e57
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 8, 2013
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
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 Code66116-480
Application NumberANDA077859
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 8, 2013
FDA Product Classification
INGREDIENTS (9)
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT