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levofloxacin

LEVOFLOXACIN TABLETS

Approved
Approval ID

ffa121b8-388f-4d7b-af48-d4aa8d9b5961

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 4, 2023

Manufacturers
FDA

Zydus Lifesciences Limited

DUNS: 918596198

Products 3

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

levofloxacin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65841-692
Application NumberANDA077652
Product Classification
M
Marketing Category
C73584
G
Generic Name
levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification

INGREDIENTS (8)

LEVOFLOXACINActive
Quantity: 500 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT

levofloxacin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65841-693
Application NumberANDA077652
Product Classification
M
Marketing Category
C73584
G
Generic Name
levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification

INGREDIENTS (8)

LEVOFLOXACINActive
Quantity: 750 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

levofloxacin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65841-691
Application NumberANDA077652
Product Classification
M
Marketing Category
C73584
G
Generic Name
levofloxacin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification

INGREDIENTS (8)

CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LEVOFLOXACINActive
Quantity: 250 mg in 1 1
Code: 6GNT3Y5LMF
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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levofloxacin - FDA Drug Approval Details