CIPROFLOXACIN
Approved
Approval ID
d9c8fcd9-bbe2-4ae7-bc44-74abd507d770
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 2, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-735
Application NumberANDA076558
Product Classification
M
Marketing Category
C73584
G
Generic Name
CIPROFLOXACIN
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2011
FDA Product Classification
INGREDIENTS (10)
CIPROFLOXACINActive
Quantity: 750 mg in 1 1
Code: 5E8K9I0O4U
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT