Ciprofloxacin hydrochloride
CIPROFLOXACIN TABLETS USPRx only
Approved
Approval ID
4144009e-e956-4fec-b5b7-a4950168e055
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2010
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-606
Application NumberANDA076089
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2010
FDA Product Classification
INGREDIENTS (12)
Ciprofloxacin hydrochlorideActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIB
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT