Ciprofloxacin
Ciprofloxacin tablets --------------- These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987
Approved
Approval ID
6fd3da0b-7428-ac8f-e053-2a91aa0aed9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Yiling Pharmaceutical, Inc.
DUNS: 079417422
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ciprofloxacin Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69117-0009
Application NumberANDA208921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin Tablets
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Ciprofloxacin Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69117-0008
Application NumberANDA208921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin Tablets
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM