Ciprofloxacin Hydrochloride
Approved
Approval ID
3e463126-78a9-4ec5-904c-0424a64d8ae8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2011
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
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 Code49349-612
Application NumberANDA075593
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2011
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 5/24/2011
BOXED WARNING
WARNING:
Fluoroquinolones, including ciprofloxacin, are associated with an increased
risk of tendinitis and tendon rupture in all ages. This risk is further
increased in older patients usually over 60 years of age, in patients taking
corticosteroid drugs, and in patients with kidney, heart or lung transplants
(SeeWARNINGS).