FDA.reportPublic FDA data

NDC 65862-626-06 - 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
65862-626
Requested NDC
65862-626-06
Package NDCs from labels
65862-626-03, 65862-626-90, 65862-626-12, 65862-626-06, 65862-626-18, 65862-626-36, 65862-626-48, 65862-626-64
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rizatriptan Benzoate - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-08HUMAN PRESCRIPTION DRUG LABEL
Rizatriptan Benzoate - Bryant Ranch PrepackBryant Ranch Prepack2026-02-04HUMAN PRESCRIPTION DRUG LABEL
Rizatriptan Benzoate - Aurobindo Pharma LimitedAurobindo Pharma Limited2025-08-06Human Prescription Drug Label
Rizatriptan Benzoate ODT - Direct RxDirect Rx2025-01-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-626-03Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING314
65862-626-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING614
65862-626-12Rizatriptan Benzoate4 in 1 CARTONTABLET, ORALLY DISINTEGRATING414
65862-626-18Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING314
65862-626-36Rizatriptan Benzoate9 in 1 BOTTLETABLET, ORALLY DISINTEGRATING914
65862-626-48Rizatriptan Benzoate18 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1814
65862-626-64Rizatriptan Benzoate1 in 1 CARTONTABLET, ORALLY DISINTEGRATING114
65862-626-90Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-626RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 8 package rows20240221_a8e37688-426c-4290-933d-54a34ae86000.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-626-03EA - Each65862-6266009d288-50b0-472b-a3ee-ac37bdee94db12013-08-02
65862-626-12EA - Each65862-626324ed076-6aa0-45e1-9188-ffe5ec7d27ab12013-08-02
65862-626-90EA - Each65862-626bd12530e-5b8c-4211-8ac9-30aa1aa96a6412014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]2

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 3 of 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rizatriptan Benzoate ODTRIZATRIPTAN BENZOATE ODTDirect Rxdb489d19-1509-c979-e053-2a95a90a44102025-01-22Warnings, Adverse reactionsExact identifier
application number: ANDA203062
ndc (package): 72189-341-09
ndc (product): 72189-341
rxcui: 312837
spl id: 2c4c5f32-a754-7f96-e063-6394a90ad938
spl set id: db489d19-1509-c979-e053-2a95a90a4410
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEDirect_Rx05150193-cc2f-8b41-e063-6394a90a184c2025-01-22Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEDirect Rxd60560d5-8e52-099d-e053-2a95a90a20af2025-01-21Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack2598cfb1-f875-43a5-aa10-246e026e96952024-12-10Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEPanacea Biotec Limited9c70370d-72ac-e062-e25c-97d57e6397ab2024-12-09Warnings, Adverse reactionsExact identifier
rxcui: 312837
rxcui: 312839
unii: WR978S7QHH
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: Z0H242BBR1
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack74971372-75c6-4682-adbf-1c8e7b748fc12024-10-01Warnings, Adverse reactionsExact identifier
application number: ANDA203062
rxcui: 312837
unii: WR978S7QHH
SpectricAGARICUS MUSCARIUS, ASPARTAME, BUFO RANA, CARCINOSIN, CEREBRUM SUIS, ETHYLICUM, HELLEBORUS NIGER, HYDROGEN, HYOSCYAMUS NIGER, KALI BROMATUM, L-DOPA, NEON, OLIBANUM (BOSWELLIA SERRATA), PLACENTA TOTALIS SUIS, SEROTONIN (HYDROCHLORIDE), STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc4ee7f979-c30d-4062-a453-27b6b0b382472024-09-23WarningsExact identifier
unii: Z0H242BBR1
SpectricETHYLICUM, KALI BROMATUM, ASPARTAME, L-DOPA, SEROTONIN (HYDROCHLORIDE), CEREBRUM SUIS, PLACENTA TOTALIS SUIS, AGARICUS MUSCARIUS, BUFO RANA, HELLEBORUS NIGER, HYOSCYAMUS NIGER, OLIBANUM (BOSWELLIA SERRATA), STRAMONIUM, THUJA OCCIDENTALIS, HELIUM, NEON, CARCINOSIN, HYDROGENDeseret Biologicals, Incd1981aca-de84-404d-8d38-3a013a5314262024-09-11WarningsExact identifier
unii: Z0H242BBR1
RizatriptanRIZATRIPTANBryant Ranch Prepack7db81532-6781-47f7-a5cd-6aeda9b8bf6f2024-08-29Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: Z0H242BBR1
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack03b5a887-d689-48a6-bd41-ae1ab4ae49902024-04-05Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack01762e5f-db9a-49b3-8da1-60967970a3182024-04-03Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Rizatriptan BenzoateRIZATRIPTAN BENZOATEGolden State Medical Supply, Inc.075f47ee-88d1-102b-e063-6394a90acbf82024-03-25Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATERising Pharma Holdings, Inc.2337e102-8df0-4e7f-81d8-5cb86cd486742024-02-19Warnings, Adverse reactionsExact identifier
application number: ANDA203062
rxcui: 312837
rxcui: 312839
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATERising Pharma Holdings, Inc.222f77ff-d3f7-40f9-989c-e5902f44ef1e2024-02-17Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAurobindo Pharma Limitedfa0f65b8-96b0-49e4-ac47-9a86fb4aa5f12024-02-17Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATENuCare Pharmaceuticals,Inc.106dd370-c09c-556a-e063-6394a90acfed2024-02-02Warnings, Adverse reactionsExact identifier
application number: ANDA203062
rxcui: 312837
unii: WR978S7QHH
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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