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 4 of 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
F15 MND-MMRYAGNUS CASTUS, ALLEGHENY MONKEYFLOWER, ANACARDIUM ORIENTALE, ARNICA MONTANA, ARNICA MONTANA FLOWER, BANANA, COMFREY, CALOCHORTUS GUNNISONII, CITRUS PARADISI, CORNUS NUTTALLII, EHRENDORFERIA CHRYSANTHA, MELILOTUS OFFICINALIS, MYOSOTIS SYLVATICA, IGNATIA AMARA, KALI BROMATUM, LAC CANINUM, ORNITHOGALUM UMBELLATUM, PEPPERMINT, PHOSPHORICUM ACIDUM, PHOSPHORUS, PINUS SYLVESTRIS, RANUNCULUS BULBOSUS, RUDBECKIA HIRTA, SAGUARO, TOXICODENDRON DIVERSILOBUM, YARROW, YERBA SANTA, ZINNIA ELEGANSApex Energetics Inc.bf3bbec4-f9e0-5a2d-e053-2a95a90ab1532024-01-08WarningsExact identifier
unii: V95R5KMY2B
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: Z0H242BBR1
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LP80c124ab-a083-4184-ba6b-199a7681b5d12023-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA203062
rxcui: 312837
unii: WR978S7QHH
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack65ae33a2-975f-4a4e-a1a5-42fe451a24342023-03-23Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
rizatriptan benzoateRIZATRIPTAN BENZOATEMacleods Pharmaceuticals Limited57ed2505-28f1-4292-b3c3-a49bf0f7c6832023-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312837
rxcui: 312839
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEA-S Medication Solutions5001b8cc-8e52-4a00-a830-3b2f79766a032023-02-06Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEUnichem Pharmaceuticals (USA), Inc.35f26d3c-268b-4114-9b5b-1c2e0b9ddfd52022-11-22Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
UNDA 19ALUMINIUM METALLICUM, DROSERA, ILLICIUM VERUM, MENTHA PIPERITA, SENEGA OFFICINALISSeroyal USA4c47f5cd-fcb3-3ecb-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: V95R5KMY2B
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAscend Laboratories, LLC07e66554-bc85-4853-9f40-1249617630a92022-09-30Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
RizatriptanRIZATRIPTANMacleods Pharmaceuticals Limited27bc2cfc-fefb-4b50-a0dc-6268c69b49022022-07-01Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
AddiclenzBETA VULGARIS, BOLDO, 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.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: Z0H242BBR1
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LP4a5b43f6-a5ea-4d6f-941f-3c19f242c8962022-05-01Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATECipla USA Inc.f462a507-921c-41c2-93ba-36003b6e89142022-01-13Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEBionpharma Inc.,91e160d6-f23f-e5e0-baec-908b2d25ce3c2021-03-02Warnings, Adverse reactionsExact identifier
rxcui: 312837
rxcui: 312839
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEUnichem Pharmaceuticals (USA), Inc.3cdeccf6-36dd-4a9e-9687-2f7cce47af5f2020-04-08Warnings, Adverse reactionsExact identifier
rxcui: 312837
rxcui: 312839
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LPf5520526-1cc5-489f-b142-92f92fec77d32020-02-01Warnings, Adverse reactionsExact identifier
rxcui: 312837
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATETeva Pharmaceuticals USA, Inc.4ef60c83-ba48-4134-968b-13800ea9b7f22019-10-01Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: Z0H242BBR1

Reported adverse events (FAERS/openFDA)#

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