FDA.reportPublic FDA data

NDC 65862-599-06 - 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
65862-599
Requested NDC
65862-599-06
Package NDCs from labels
65862-599-03, 65862-599-90, 65862-599-12, 65862-599-06, 65862-599-18
Manufacturer
Bryant Ranch Prepack
Effective date
2024-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rizatriptan Benzoate - Bryant Ranch PrepackBryant Ranch Prepack2024-12-10HUMAN PRESCRIPTION DRUG LABEL
Rizatriptan Benzoate - Aurobindo Pharma LimitedAurobindo Pharma Limited2024-02-17Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-599-03Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET314
65862-599-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET614
65862-599-12Rizatriptan Benzoate4 in 1 CARTONTABLET414
65862-599-18Rizatriptan Benzoate3 in 1 CARTONTABLET314
65862-599-90Rizatriptan Benzoate3 in 1 CARTONTABLET314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-599RIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 5 package rows20240218_fa0f65b8-96b0-49e4-ac47-9a86fb4aa5f1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-599-03EA - Each65862-599a46c2ff5-ea1c-48bc-9654-a939e0e88ea212013-02-13
65862-599-12EA - Each65862-5992f24a7a6-89e0-484d-96c0-86e89e81df4012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3

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 6 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack65ae33a2-975f-4a4e-a1a5-42fe451a24342023-03-23Warnings, Adverse reactionsExact identifier
rxcui: 312840
unii: WR978S7QHH
rizatriptan benzoateRIZATRIPTAN BENZOATEMacleods Pharmaceuticals Limited57ed2505-28f1-4292-b3c3-a49bf0f7c6832023-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEA-S Medication Solutions5001b8cc-8e52-4a00-a830-3b2f79766a032023-02-06Warnings, Adverse reactionsExact identifier
rxcui: 314209
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEUnichem Pharmaceuticals (USA), Inc.35f26d3c-268b-4114-9b5b-1c2e0b9ddfd52022-11-22Warnings, Adverse reactionsExact identifier
rxcui: 314209
rxcui: 312840
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAscend Laboratories, LLC07e66554-bc85-4853-9f40-1249617630a92022-09-30Warnings, Adverse reactionsExact identifier
rxcui: 314209
rxcui: 312840
unii: WR978S7QHH
RizatriptanRIZATRIPTANMacleods Pharmaceuticals Limited27bc2cfc-fefb-4b50-a0dc-6268c69b49022022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 314209
rxcui: 312840
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LP4a5b43f6-a5ea-4d6f-941f-3c19f242c8962022-05-01Warnings, Adverse reactionsExact identifier
application number: ANDA202490
rxcui: 314209
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATECipla USA Inc.f462a507-921c-41c2-93ba-36003b6e89142022-01-13Warnings, Adverse reactionsExact identifier
rxcui: 314209
rxcui: 312840
unii: WR978S7QHH
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEBionpharma Inc.,91e160d6-f23f-e5e0-baec-908b2d25ce3c2021-03-02Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEUnichem Pharmaceuticals (USA), Inc.3cdeccf6-36dd-4a9e-9687-2f7cce47af5f2020-04-08Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEProficient Rx LPf5520526-1cc5-489f-b142-92f92fec77d32020-02-01Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATETeva Pharmaceuticals USA, Inc.4ef60c83-ba48-4134-968b-13800ea9b7f22019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 314209
rxcui: 312840
unii: WR978S7QHH

Reported adverse events (FAERS/openFDA)#

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