Zolmitriptan OD (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2.5 mg BLISTER CARTON:

NDC 59746-461-16
CADISTA TM
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
Pharmacist: Dispense the accompanying patient information leaflet to each patient.
6 (2 x 3) Unit-Dose Tablets Rx Only

2.5 mg carton
(click image for full-size original)

2.5 mg 6’s Blister Carton

2.5 mg Blister Foil:

2.5 mg foil
(click image for full-size original)

5 mg BLISTER CARTON:
NDC 59746-462-13
CADISTATM
Zolmitriptan Orally Disintegrating Tablets
5 mg
Pharmacist: Dispense the accompanying patient information leaflet to each patient.3 (1 x 3) Unit-Dose Tablets Rx Only

5 mg blister carton
(click image for full-size original)

5 mg 3’s Blister Carton

5 mg BLISTER FOIL:

5 mg blister foil
(click image for full-size original)
ZOLMITRIPTAN OD zolmitriptan tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-461
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zolmitriptan (Zolmitriptan) Zolmitriptan 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Magnesium Aluminometasilicate Type I-a
Silicon Dioxide
Sodium Lauryl Sulfate
Hydroxypropyl Cellulose, Low Substituted
Dimethylaminoethyl Methacrylate — Butyl Methacrylate — Methyl Methacrylate Copolymer
Talc
Mannitol
Crospovidone, Unspecified
Acesulfame Potassium
Magnesium Stearate
Peppermint
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor PEPPERMINT Imprint Code C;J
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-461-16 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (59746-461-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202956 09/17/2015
ZOLMITRIPTAN OD zolmitriptan tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-462
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zolmitriptan (Zolmitriptan) Zolmitriptan 5 mg
Inactive Ingredients
Ingredient Name Strength
Magnesium Aluminum Silicate Type Ia
Silicon Dioxide
Sodium Lauryl Sulfate
Hydroxypropyl Cellulose, Low Substituted
Dimethylaminoethyl Methacrylate — Butyl Methacrylate — Methyl Methacrylate Copolymer
Talc
Mannitol
Crospovidone, Unspecified
Acesulfame Potassium
Magnesium Stearate
Peppermint
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor PEPPERMINT Imprint Code C;K
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-462-13 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (59746-462-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202956 09/17/2015
Labeler — Jubilant Cadista Pharmaceuticals Inc. (022490515)
Registrant — Jubilant Generics Limited (650801538)
Establishment
Name Address ID/FEI Operations
Jubilant Generics Limited 650369221 MANUFACTURE (59746-461), MANUFACTURE (59746-462)

Revised: 09/2015 Jubilant Cadista Pharmaceuticals Inc.

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