FDA.reportPublic FDA data

NDC 59746-446-13 - Rizatriptan Benzoate

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
59746-446
Requested NDC
59746-446-13
Package NDCs from labels
59746-446-13, 59746-446-14
Manufacturer
Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited
Effective date
2018-12-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rizatriptan - Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics LimitedJubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited2018-12-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-446-142026-01-05C16284748780-1f386c649-c5a4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998
59746-446-142023-01-30C16284748780-1f386c649-c5a4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-446RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]6Legacy NDC20181217_42454df9-ffd1-d8c0-f6fb-05198ad8a432.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Rizatriptan BenzoateACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
RizatriptanACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G9RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
CrospovidoneINACTIVE INGREDIENT68401960MKRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
HypromellosesINACTIVE INGREDIENT3NXW29V3WORIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
MannitolINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
PeppermintINACTIVE INGREDIENTV95R5KMY2BRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Sodium Stearyl FumarateINACTIVE INGREDIENT7CV7WJK4UIRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
StrawberryINACTIVE INGREDIENT4J2TY8Y81VRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3

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 19 of 34 · 674 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba993f4-97af-4119-e053-2995a90a126d2025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
PRIDICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.d22eca2f-d7e6-3412-e053-2995a90a63842025-02-05WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts 12 IN 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAZettl Health Inc.25ba49d0-0369-3666-e063-6294a90a71c42025-02-04Exact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 6X 12SILICEAZettl Health Inc.2d5d1bf7-3754-1f60-e063-6294a90aee062025-02-04Exact identifier
unii: ETJ7Z6XBU4
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LPe7414f2d-d7cf-41e5-b457-f5850e8bb7a72025-02-01Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAsclemed USA, Inc.8fa794f4-4253-485d-b4ee-9861780313392025-01-27Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Rizatriptan Benzoate ODTRIZATRIPTAN BENZOATE ODTDirect Rxdb489d19-1509-c979-e053-2a95a90a44102025-01-22Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEDirect_Rx05150193-cc2f-8b41-e063-6394a90a184c2025-01-22Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Lemon QuinceLEMON QUINCEUriel Pharmacy Inc332e4a40-e0f3-11de-8a39-0800200c9a662025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEDirect Rxd60560d5-8e52-099d-e053-2a95a90a20af2025-01-21Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Hydration ComplexBETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f60a2ab8-4146-4995-9bc6-be2660b175402025-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
D-34OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLADNA Labs, Inc.607e21a3-2229-48fa-b12c-ebd3130b99962025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-33ATROPA BELLADONNA, BUFO BUFO CUTANEOUS GLAND, COPPER, ANEMONE PRATENSIS, SILICON DIOXIDE, AND ZINCDNA Labs, Inc.26f9bf6d-6038-42e8-b8c1-6c94ac4929af2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-86ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDEDNA Labs, Inc.54fa62d3-c129-4826-a794-f3dcc6b855bf2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-57ARSENIC TRIIODIDE, PHOSPHORUS, TEUCRIUM SCORODONIA FLOWERING TOP, SILICON DIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND LYCOPODIUM CLAVATUM SPOREDNA Labs, Inc.81cc16e7-921b-4b57-abeb-c44b9d72e4f32025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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