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 13 of 34 · 674 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
EELHOE Tanning MistGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.32670243-957d-3a95-e063-6394a90a58932025-11-27WarningsExact identifier
unii: 4J2TY8Y81V
RizatriptanRIZATRIPTANBryant Ranch Prepackf000d96c-42a0-4aac-96ca-8cef289979ce2025-11-26Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
XIMONTH Quick EssenceSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.4256f607-c9cf-cd0f-e063-6394a90a54872025-11-26WarningsExact identifier
unii: V95R5KMY2B
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b597504a-c667-225c-e053-2a95a90ac7042025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDONG IL PHARMS CO.,LTD4476923a-48f1-9f72-e063-6394a90a07082025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD44768dd1-b132-c33b-e063-6294a90accd42025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
Gout Pain ManagementARNICA MONTANA, URTICA URENS, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFForces of Nature9276fe9c-d9a2-4cef-986c-5d7d39f2d6a12025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph HPACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CAUSTICUM, ECHINACEA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LOBELIA INFLATA, LOMATIUM DISSECTUM, LUNG, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, SYMPHYTUM OFFICINALEEnergique, Inc.17aa9d9c-3d32-4963-91db-d1e96717e7ad2025-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
CONSTIPATIONMAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEANatural Creations, Inc.d2e24f5a-747b-4d62-bbdf-16c0e43becdb2025-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumo SarcodeTEUCRIUM SCORODONIA, ARSENICUM IODATUM, LUNG (BOVINE), CALCAREA PHOSPHORICA, STANNUM METALLICUM, CARBO VEGETABILIS, PHELLANDRIUM AQUATICUM, SILICEA, SULPHURNutritional Specialties, Inc.c3a7cf75-723e-4fb9-8ff8-ae8f73a0900d2025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
ColdBAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEANatural Creations, Incc45d1d8f-24be-4c13-8c4b-3889624214152025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Inc.5590d577-3a98-49b8-bb12-ddd7f5cfd0802025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
Dizziness HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM,Energique, Inc.0bf53ecc-c2ad-40b5-b921-7c10a1b006262025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
Formica Stibium comp.FORMICA STIBIUM COMP.Uriel Pharmacy Inc.439073f2-1dee-4b4e-a65e-74aee1c73c2b2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Lavender Quartz Ear OilLAVENDER QUARTZ EAR OILUriel Pharmacy Inc.b1a8d75c-77a9-40a7-8dd8-9c32cac31d2c2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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