FDA.reportPublic FDA data

NDC 65862-600-06 - 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
65862-600
Requested NDC
65862-600-06
Package NDCs from labels
65862-600-03, 65862-600-90, 65862-600-12, 65862-600-06, 65862-600-18
Manufacturer
DIRECT RX
Effective date
2026-03-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RIZATRIPTAN BENZOATE - DIRECT RXDIRECT RX2026-03-17HUMAN PRESCRIPTION DRUG LABEL
Rizatriptan Benzoate - Aurobindo Pharma LimitedAurobindo Pharma Limited2024-02-17Human Prescription Drug Label
Rizatriptan Benzoate - Proficient Rx LPProficient Rx LP2022-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-600-03Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET314
65862-600-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET614
65862-600-12Rizatriptan Benzoate4 in 1 CARTONTABLET414
65862-600-18Rizatriptan Benzoate3 in 1 CARTONTABLET314
65862-600-90Rizatriptan Benzoate3 in 1 CARTONTABLET314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-600RIZATRIPTAN 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
65862-600-03EA - Each65862-6007ea2a346-4cdc-463c-a0bb-a392009716ad12013-02-13
65862-600-12EA - Each65862-60056ce3e0e-3e92-4136-8ee7-a9899a6ac6f112013-02-13

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 31 of 35 · 685 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAOHM PHARMA INC.044a7174-f7a3-490f-9cad-01f2665d75752022-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Rizatriptan BenzoateRIZATRIPTAN BENZOATEUnichem Pharmaceuticals (USA), Inc.35f26d3c-268b-4114-9b5b-1c2e0b9ddfd52022-11-22Warnings, Adverse reactionsExact identifier
rxcui: 314209
rxcui: 312840
unii: WR978S7QHH
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAscend Laboratories, LLC07e66554-bc85-4853-9f40-1249617630a92022-09-30Warnings, Adverse reactionsExact identifier
rxcui: 314209
rxcui: 312840
unii: WR978S7QHH
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
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
ndc (package): 71205-644-12
ndc (product): 71205-644
rxcui: 314209
spl id: fad5d266-a87f-413a-b644-8ebbe93e7534
spl set id: 4a5b43f6-a5ea-4d6f-941f-3c19f242c896
unii: WR978S7QHH
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe Mexico, S.A. de C.V.3e2e5f52-db54-4635-83a8-a67a683c093c2022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da807eb3-34a3-61b9-e053-2995a90a0e212022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da80a5ea-f603-719e-e053-2995a90a97102022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da81b21a-090a-dabf-e053-2995a90aa05e2022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da821d05-b2f0-3582-e053-2a95a90afe592022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da717cf0-54af-c4e2-e053-2995a90ac97c2022-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
Rizatriptan BenzoateRIZATRIPTAN BENZOATECipla USA Inc.f462a507-921c-41c2-93ba-36003b6e89142022-01-13Warnings, Adverse reactionsExact identifier
application number: ANDA204339
ndc (product): 69097-865
rxcui: 314209
rxcui: 312840
spl id: 6ace7fac-e700-4a32-95ce-07ffbd0201ea
spl set id: f462a507-921c-41c2-93ba-36003b6e8914
unii: WR978S7QHH
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4
Lyme Disease Support 2ARGENTUM NITRICUM, ASTRAGALUS MENZIESII, CALCAREA SULPHURICA, CUPRUM ARSENICOSUM, DNA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RNA, SILICEA.OHM PHARMA INC.13b4b78b-f9f7-4cf6-8f43-61679160086b2021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4
Lyme Disease Support 1ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.OHM PHARMA INC.035e75d6-aeef-4dfd-b076-9d3d8e4a50862021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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