Label: ZOLMITRIPTAN tablet, orally disintegrating
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NDC Code(s):
65841-767-01,
65841-767-06,
65841-767-10,
65841-767-16, view more65841-767-30, 65841-767-69, 65841-767-77, 65841-767-86, 65841-768-01, 65841-768-06, 65841-768-10, 65841-768-16, 65841-768-30, 65841-768-77, 65841-768-82, 65841-768-87
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 14, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZOLMITRIPTAN
zolmitriptan tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-767 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW) ZOLMITRIPTAN 2.5 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE/MOTTLED WHITE TO CREAM WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor ORANGE (ORANGE) Imprint Code 715 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-767-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2013 2 NDC:65841-767-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2013 3 NDC:65841-767-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2013 4 NDC:65841-767-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2013 5 NDC:65841-767-86 1 in 1 CARTON 05/16/2013 5 NDC:65841-767-69 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:65841-767-77 10 in 1 CARTON 05/16/2013 6 NDC:65841-767-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202890 05/16/2013 ZOLMITRIPTAN
zolmitriptan tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-768 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW) ZOLMITRIPTAN 5 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (WHITE/MOTTLED WHITE TO CREAM WHITE) Score no score Shape ROUND (ROUND) Size 9mm Flavor ORANGE (ORANGE) Imprint Code 717 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-768-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2013 2 NDC:65841-768-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2013 3 NDC:65841-768-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2013 4 NDC:65841-768-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2013 5 NDC:65841-768-82 1 in 1 CARTON 05/16/2013 5 NDC:65841-768-87 3 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:65841-768-77 10 in 1 CARTON 05/16/2013 6 NDC:65841-768-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202890 05/16/2013 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-767, 65841-768) , MANUFACTURE(65841-767, 65841-768)