Ciprofloxacin
CIPROFLOXACIN TABLETS, USP
Approved
Approval ID
99a81fda-81dc-40b3-b55a-165b6e4ca4ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 3
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 Code52959-734
Application NumberANDA076794
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciprofloxacin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2011
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ciprofloxacin hydrochlorideActive
Quantity: 750 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ciprofloxacin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-730
Application NumberANDA076794
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciprofloxacin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2011
FDA Product Classification
INGREDIENTS (10)
ciprofloxacin hydrochlorideActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
ciprofloxacin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-739
Application NumberANDA076794
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciprofloxacin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2011
FDA Product Classification
INGREDIENTS (10)
ciprofloxacin hydrochlorideActive
Quantity: 250 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT