LEVOFLOXACIN- levofloxacin tablet, film coated 
Zydus Lifesciences Limited

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LEVOFLOXACIN TABLETS

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-691-18 in bottle of 50 tablets

Levofloxacin Tablets USP, 250 mg

Rx only

50 tablets

Levofloxacin Tablets, 250 mg

NDC 65841-692-18 in bottle of 50 tablets

Levofloxacin Tablets USP, 500 mg

Rx only

50 tablets

Levofloxacin Tablets, 500 mg

NDC 65841-693-06 in bottle of 30 tablets

Levofloxacin Tablets USP, 750 mg

Rx only

30 tablets

Levofloxacin Tablets, 750 mg
LEVOFLOXACIN 
levofloxacin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-691
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (MODIFIED CAPSULE) Size15mm
FlavorImprint Code ZC55
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-691-1850 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
2NDC:65841-691-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
3NDC:65841-691-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07765211/10/2012
LEVOFLOXACIN 
levofloxacin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-692
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (MODIFIED CAPSULE) Size19mm
FlavorImprint Code ZC56
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-692-1850 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
2NDC:65841-692-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
3NDC:65841-692-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
4NDC:65841-692-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07765211/10/2010
LEVOFLOXACIN 
levofloxacin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-693
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS750 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (MODIFIED CAPSULE) Size22mm
FlavorImprint Code ZC57
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-693-1850 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
2NDC:65841-693-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
3NDC:65841-693-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
4NDC:65841-693-9220 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2022
5NDC:65841-693-0630 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07765211/10/2012
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-691, 65841-692, 65841-693) , MANUFACTURE(65841-691, 65841-692, 65841-693)

Revised: 8/2024
Document Id: 5aeae448-e53f-4954-9dd9-2bcc3dd791d4
Set id: ffa121b8-388f-4d7b-af48-d4aa8d9b5961
Version: 11
Effective Time: 20240816
 
Zydus Lifesciences Limited