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Ciprofloxacin

These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP. CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet for oral use Initial U.S. Approval: 1987

Approved
Approval ID

37527eca-115e-4582-88cd-bba851ac6069

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 6, 2023

Manufacturers
FDA

Carlsbad Technology, Inc.

DUNS: 781047246

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 Code61442-224
Application NumberANDA076126
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 6, 2023
FDA Product Classification

INGREDIENTS (5)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 750 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT

Ciprofloxacin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61442-222
Application NumberANDA076126
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 6, 2023
FDA Product Classification

INGREDIENTS (5)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM

Ciprofloxacin Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61442-223
Application NumberANDA076126
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 6, 2023
FDA Product Classification

INGREDIENTS (5)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM

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Ciprofloxacin - FDA Drug Approval Details