Ciprofloxacin Hydrochloride
Approved
Approval ID
9dac97a5-c992-4601-af93-138bfe2302a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 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 DateMarch 15, 2011
FDA Product Classification
INGREDIENTS (9)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT