FDA.reportPublic FDA data

NDC 65841-768-87 - Zolmitriptan

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65841-768
Requested NDC
65841-768-87
Package NDCs from labels
65841-768-06, 65841-768-16, 65841-768-01, 65841-768-10, 65841-768-87, 65841-768-82, 65841-768-30, 65841-768-77
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolmitriptan - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-768-01Zolmitriptan100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1006
65841-768-06Zolmitriptan30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING306
65841-768-10Zolmitriptan1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10006
65841-768-16Zolmitriptan90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING906
65841-768-30Zolmitriptan10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
65841-768-77Zolmitriptan10 in 1 CARTONTABLET, ORALLY DISINTEGRATING106
65841-768-82Zolmitriptan1 in 1 CARTONTABLET, ORALLY DISINTEGRATING16
65841-768-87Zolmitriptan3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-768ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 8 package rows20240817_aae2d9cb-9938-4032-961f-f0afd1958b5d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLMITRIPTANACTIVE INGREDIENT2FS66TH3YWZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ZOLMITRIPTANACTIVE MOIETY2FS66TH3YWZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 38 · 744 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BioMicroneedle PDRN CreamSILICON DIOXIDEGuangzhou Shengyanghui Industrial Trading Co., Ltd48e2edae-94ea-c42e-e063-6394a90a907b2026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd487c5036-0eb0-ada9-e063-6394a90aa02e2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD487cd5b9-28f3-392d-e063-6394a90a9ba12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd487d52d1-8853-bc90-e063-6394a90ab91d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD487d689d-ebdd-43c3-e063-6294a90af0e22026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD487da363-1d01-8cdc-e063-6294a90ac24d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Berberis QuartzBERBERIS QUARTZUriel Pharmacy Inc.5da48d70-1140-495d-b672-0e55c04196e12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Amber AmethystAMBER AMETHYSTUriel Pharmacy, Inc4837e805-a777-c1fa-e063-6294a90ae9c42026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Organophosphate Combination 9309ORGANOPHOSPHATE COMBINATIONProfessional Complementary Health Formulasf777015f-1df6-4821-af63-543175313aba2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Low Vaccinosis Nosode 4024LOW VACCINOSIS NOSODEProfessional Complementary Health Formulasf347ac8f-ac05-46ef-91a3-9f7e000347682026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Second Chakra (Sacral) 7302SECOND CHAKRA (SACRAL)Professional Complementary Health Formulasea8a69d3-66fc-4b21-bfdd-c207dd2935892026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 8012SILICEAProfessional Complementary Health Formulasa2a1eae8-24c8-44dd-9b9d-1826fa7164332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.