ZOLMITRIPTAN- zolmitriptan tablet, orally disintegrating 
Cadila Healthcare Limited

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ZOLMITRIPTAN ORALLY DISTRAGING TABLETS

NDC 65841-767-10 in bottle of 1000 Tablets

Zolmitriptan Orally Disintegrating Tablets, 2.5 mg

Rx only

1000 Tablets

Zolmitriptan OD Tablets, 2.5 mg

NDC 65841-768-10 in bottle of 1000 Tablets

Zolmitriptan Orally Disintegrating Tablets, 5 mg

Rx only

1000 Tablets

Zolmitritan OD Tablets, 5 mg
ZOLMITRIPTAN 
zolmitriptan tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-767
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 CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ORANGE (UNII: 5EVU04N5QU)  
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITE (WHITE/MOTTLED WHITE TO CREAM WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorORANGE (ORANGE) Imprint Code 715
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-767-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
2NDC:65841-767-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
3NDC:65841-767-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
4NDC:65841-767-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
5NDC:65841-767-861 in 1 CARTON05/16/2013
5NDC:65841-767-696 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:65841-767-7710 in 1 CARTON05/16/2013
6NDC:65841-767-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20289005/16/2013
ZOLMITRIPTAN 
zolmitriptan tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-768
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW) ZOLMITRIPTAN5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ORANGE (UNII: 5EVU04N5QU)  
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITE (WHITE/MOTTLED WHITE TO CREAM WHITE) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorORANGE (ORANGE) Imprint Code 717
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-768-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
2NDC:65841-768-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
3NDC:65841-768-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
4NDC:65841-768-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
5NDC:65841-768-821 in 1 CARTON05/16/2013
5NDC:65841-768-873 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:65841-768-7710 in 1 CARTON05/16/2013
6NDC:65841-768-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20289005/16/2013
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-767, 65841-768) , MANUFACTURE(65841-767, 65841-768)

Revised: 9/2020
Document Id: 8a390174-b032-4c54-966b-a80b6fbb3741
Set id: aae2d9cb-9938-4032-961f-f0afd1958b5d
Version: 4
Effective Time: 20200914
 
Cadila Healthcare Limited