FDA.reportPublic FDA data

NDC 80425-0535-01 - 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
80425-0535
Requested NDC
80425-0535-01
Package NDCs from labels
80425-0535-1, 80425-0535-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-10-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rizatriptan Benzoate - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-10-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0535-1Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING32
80425-0535-1Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0535-1EA - Each80425-0535a6c5dec4-4c10-4ef8-9eba-98634392d71812025-12-16

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 2 of 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANPINGHUA Glucosamine Chondroitin PatchPEPPERMINT, CAMPHOR, BORNEOLHenan Lijitang Medical Technology Co., Ltd.42f8c2ae-50a2-2358-e063-6394a90a59792025-11-06WarningsExact identifier
unii: V95R5KMY2B
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack6391d2a1-252e-4e50-9d80-4dce12eabc8f2025-11-06Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEA-S Medication Solutions187204ef-5370-476a-84b1-e3c54b60c6c22025-11-06Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
RizatriptanRIZATRIPTANA-S Medication Solutions34395ed2-97b7-4220-9089-0e90169d30832025-11-05Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAdvanced Rx of Tennessee, LLC4137a02e-dcec-c14c-e063-6294a90aa44f2025-10-21Warnings, Adverse reactionsExact identifier
application number: ANDA203062
ndc (package): 80425-0535-1
ndc (product): 80425-0535
ndc11 (package): 80425053501
rxcui: 312837
spl id: 41ad1e53-e436-552a-e063-6394a90ac92a
spl set id: 4137a02e-dcec-c14c-e063-6294a90aa44f
unii: WR978S7QHH
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATECreekwood Pharmaceuticals LLCb517896b-167e-47d5-801d-7458f80e8ee22025-10-09Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
FUNGAL NAILS REPAIRING ESSENCEPEPPERMINT OILZhenping Renren Industry Co., Ltd.3e82649c-d784-d64c-e063-6294a90ac95d2025-09-11WarningsExact identifier
unii: V95R5KMY2B
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Rizatriptan BenzoateRIZATRIPTAN BENZOATEGolden State Medical Supply, Inc.07605de4-bef2-70e8-e063-6394a90a33cc2025-08-20Warnings, Adverse reactionsExact identifier
application number: ANDA203062
rxcui: 312837
rxcui: 312839
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAurobindo Pharma Limiteda8e37688-426c-4290-933d-54a34ae860002025-08-06Warnings, Adverse reactionsExact identifier
application number: ANDA203062
rxcui: 312837
rxcui: 312839
unii: WR978S7QHH
Insecticides/Pest/Food Additives DetoxBOLDO, 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, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z0H242BBR1
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
RIZAFILMRIZATRIPTAN BENZOATEGensco Laboratories LLCfa32794e-d26d-e0bf-e053-6294a90abb0e2025-04-27Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: Z0H242BBR1
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
HIONFURT Motion SicknessMOTION SICKNESS PREVENT NAUSEA,DIZZINESS VOMITINGPuning Huiyu E-Commerce Co., Ltd.2e31419e-3ccd-d7b5-e063-6394a90ac7652025-02-15WarningsExact identifier
unii: V95R5KMY2B
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LPe7414f2d-d7cf-41e5-b457-f5850e8bb7a72025-02-01Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAsclemed USA, Inc.8fa794f4-4253-485d-b4ee-9861780313392025-01-27Warnings, Adverse reactionsExact identifier
application number: ANDA203062
rxcui: 312837
rxcui: 312839
unii: WR978S7QHH

Reported adverse events (FAERS/openFDA)#

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