FDA.reportPublic FDA data

NDC 68071-3568-08 - 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
68071-3568
Requested NDC
68071-3568-08
Package NDCs from labels
68071-3568-8, 68071-3568-08
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rizatriptan Benzoate - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-02-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3568-8Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING61
68071-3568-8Rizatriptan Benzoate18 in 1 CARTONTABLET, ORALLY DISINTEGRATING181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3568RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 2 package rows20240203_106dd370-c09c-556a-e063-6394a90acfed.zip

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
rxcui: 312837
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
ndc (product): 57237-086
rxcui: 312837
rxcui: 312839
spl id: e693bf18-c909-41c8-bfd5-21cb4458b925
spl set id: 2337e102-8df0-4e7f-81d8-5cb86cd48674
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
ndc (package): 68071-3568-8
ndc (product): 68071-3568
ndc11 (package): 68071356808
rxcui: 312837
spl id: 106dcf34-d1e8-5360-e063-6394a90a7e8c
spl set id: 106dd370-c09c-556a-e063-6394a90acfed
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.