Ciprofloxacin
These highlights do not include all the information needed to use CIPROFLOXACIN INJECTION safely and effectively. See full prescribing information for CIPROFLOXACIN INJECTION. CIPROFLOXACIN injection, for intravenous use Initial U.S. Approval: 1987
Approved
Approval ID
e82f52f2-ecf8-4c04-a206-f3253b265903
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 10, 2020
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 6
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 Code36000-029
Application NumberANDA078024
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 10, 2020
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEInactive
Quantity: 50 mg in 1 mL
Code: LX22YL083G
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
CIPROFLOXACINActive
Quantity: 2 mg in 1 mL
Code: 5E8K9I0O4U
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ciprofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36000-008
Application NumberANDA078024
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 10, 2020
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEInactive
Quantity: 50 mg in 1 mL
Code: LX22YL083G
Classification: IACT
CIPROFLOXACINActive
Quantity: 2 mg in 1 mL
Code: 5E8K9I0O4U
Classification: ACTIB
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Ciprofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36000-009
Application NumberANDA078024
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 10, 2020
FDA Product Classification
INGREDIENTS (5)
DEXTROSE MONOHYDRATEInactive
Quantity: 50 mg in 1 mL
Code: LX22YL083G
Classification: IACT
CIPROFLOXACINActive
Quantity: 2 mg in 1 mL
Code: 5E8K9I0O4U
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
Ciprofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36000-010
Application NumberANDA078062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 10, 2020
FDA Product Classification
INGREDIENTS (4)
CIPROFLOXACINActive
Quantity: 10 mg in 1 mL
Code: 5E8K9I0O4U
Classification: ACTIB
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Ciprofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36000-011
Application NumberANDA078062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 10, 2020
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CIPROFLOXACINActive
Quantity: 10 mg in 1 mL
Code: 5E8K9I0O4U
Classification: ACTIB
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Ciprofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36000-030
Application NumberANDA078024
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 10, 2020
FDA Product Classification
INGREDIENTS (5)
CIPROFLOXACINActive
Quantity: 2 mg in 1 mL
Code: 5E8K9I0O4U
Classification: ACTIB
DEXTROSE MONOHYDRATEInactive
Quantity: 50 mg in 1 mL
Code: LX22YL083G
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT