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Ciprofloxacin

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 useInitial U.S. Approval: 1987

Approved
Approval ID

0ce2221d-940f-4c07-ba2e-fccb491f6b9b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 1, 2025

Manufacturers
FDA

Proficient Rx LP

DUNS: 079196022

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ciprofolxacin

PRODUCT DETAILS

NDC Product Code82804-130
Application NumberANDA208921
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 1, 2025
Generic NameCiprofolxacin

INGREDIENTS (10)

CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
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Ciprofloxacin - FDA Approval | MedPath