CIPROFLOXACIN
CIPROFLOXACIN TABLETS, USP
Approved
Approval ID
4ce6888c-e639-4a0c-8490-2a78bcaa41e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 10, 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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10544-607
Application NumberANDA075593
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 10, 2010
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Ciprofloxacin hydrochlorideActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
HYPROMELLOSE 2910 (5 CPS)Inactive
Code: R75537T0T4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT