FDA.reportPublic FDA data

NDC 65862-626-03 - 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
65862-626-03
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 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
ndc (package): 70518-4362-0
ndc (product): 70518-4362
rxcui: 312837
spl id: 5afde13b-1141-4f33-e063-6394a90aafe2
spl set id: 1e547fac-a9e5-4c7b-adba-4e6b75141183
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
ndc (package): 71335-2982-1
ndc (product): 71335-2982
rxcui: 312837
spl id: f8d2892f-9943-4084-9b22-d1eabc695ac3
spl set id: 11a7f243-3a8b-41fd-a9fa-1dd2dcafab93
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.