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 1 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rizatriptan BenzoateRIZATRIPTAN BENZOATEREMEDYREPACK INC.1e547fac-a9e5-4c7b-adba-4e6b751411832026-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA203062
rxcui: 312837
unii: WR978S7QHH
RIZAFILMRIZATRIPTAN BENZOATEA-S Medication Solutions8e36b946-cf2a-44d9-9ba7-4385cfe6b3602026-08-28Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEDIRECT RX673d584c-0691-d2fb-e053-2991aa0a77972026-03-17Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEDirect_Rxf754388d-77f1-0d8d-e053-6394a90a7b7e2026-03-17Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan Benzoate ODTRIZATRIPTAN BENZOATE ODTDirect_rx2c29e066-c018-22e7-e063-6294a90a035c2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312837
unii: WR978S7QHH
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEdirect rxb3d981bc-3c9e-8a9e-e053-2995a90a8f652026-03-05Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack11a7f243-3a8b-41fd-a9fa-1dd2dcafab932026-02-04Warnings, Adverse reactionsExact identifier
application number: ANDA203062
rxcui: 312837
unii: WR978S7QHH
MAXALTRIZATRIPTAN BENZOATEOrganon LLC007b4644-e0e7-4863-9ae3-fe09676b3f5f2026-01-29Warnings, Adverse reactionsExact identifier
rxcui: 312837
unii: WR978S7QHH
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: Z0H242BBR1
Thio Combination 9306THIO COMBINATIONProfessional Complementary Health Formulas36e84795-bfb4-4483-9a2c-e14131ce1bea2026-01-08WarningsExact identifier
unii: Z0H242BBR1
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
RizatriptanRIZATRIPTANBryant Ranch Prepackf000d96c-42a0-4aac-96ca-8cef289979ce2025-11-26Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
XIMONTH Quick EssenceSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.4256f607-c9cf-cd0f-e063-6394a90a54872025-11-26WarningsExact identifier
unii: V95R5KMY2B
SYMBRAVOMELOXICAM, RIZATRIPTANAxsome Therapeutics, Inc.dcf1ecd1-08a0-8e47-e053-2a95a90abdc72025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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