ZOLMITRIPTAN - zolmitriptan tablet, film coated 
Zydus Lifesciences Limited

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ZOLMITRIPTAN TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-765-86 in unit-dose blister cartons of 6 (1 x 6) unit dose tablets

Zolmitriptan Tablets, 2.5 mg

Rx only

100 tablets

ZYDUS

 

Zolmitriptan tablets, 2.5 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-766-82 in unit-dose blister cartons of 3 (1 x 3) unit dose tablets

Zolmitriptan Tablets, 5 mg

Rx only

100 tablets

ZYDUS

Zolmitriptan Tablets, 5 mg
ZOLMITRIPTAN 
zolmitriptan tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-765
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW) ZOLMITRIPTAN2.5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW to YELLOW) Score2 pieces
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-765-861 in 1 CARTON11/12/2018
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20301911/12/2018
ZOLMITRIPTAN 
zolmitriptan tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-766
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW) ZOLMITRIPTAN5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGE (LIGHT ORANGE TO ORANGE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 714
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-766-821 in 1 CARTON11/12/2018
13 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20301911/12/2018
Labeler - Zydus Lifesciences Limited (918596198)

Revised: 10/2022
Document Id: 5dab8979-c3a9-4317-8144-17eb77713742
Set id: 3f12276b-835b-4bc3-84b4-4996948a01c0
Version: 4
Effective Time: 20221017
 
Zydus Lifesciences Limited