FDA.reportPublic FDA data

NDC 59746-446-13 - 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
59746-446
Requested NDC
59746-446-13
Package NDCs from labels
59746-446-13, 59746-446-14
Manufacturer
Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited
Effective date
2018-12-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rizatriptan - Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics LimitedJubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited2018-12-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-446-142026-01-05C16284748780-1f386c649-c5a4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998
59746-446-142023-01-30C16284748780-1f386c649-c5a4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use rizatriptan benzoate orally disintegrating tablets safely and effectively. See full prescribing information for rizatriptan benzoate orally disintegrating tablets. Rizatriptan Benzoate Orally Disintegrating Tablets Initial U.S. Approval: 1998

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-446RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]6Legacy NDC20181217_42454df9-ffd1-d8c0-f6fb-05198ad8a432.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Rizatriptan BenzoateACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
RizatriptanACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G9RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
CrospovidoneINACTIVE INGREDIENT68401960MKRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
HypromellosesINACTIVE INGREDIENT3NXW29V3WORIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
MannitolINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
PeppermintINACTIVE INGREDIENTV95R5KMY2BRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Sodium Stearyl FumarateINACTIVE INGREDIENT7CV7WJK4UIRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
StrawberryINACTIVE INGREDIENT4J2TY8Y81VRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]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 8 of 35 · 696 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low Vaccinosis Nosode 4024LOW VACCINOSIS NOSODEProfessional Complementary Health Formulasf347ac8f-ac05-46ef-91a3-9f7e000347682026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Second Chakra (Sacral) 7302SECOND CHAKRA (SACRAL)Professional Complementary Health Formulasea8a69d3-66fc-4b21-bfdd-c207dd2935892026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 8012SILICEAProfessional Complementary Health Formulasa2a1eae8-24c8-44dd-9b9d-1826fa7164332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Travel Immunization Detox 6033TRAVEL IMMUNIZATION DETOXProfessional Complementary Health Formulasb74abfad-fe22-476c-9692-07d66cc15ac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Thymus Drops 5027THYMUS DROPSProfessional Complementary Health Formulas8d7c42f7-02ae-4992-986f-4743151ad3bb2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Rose Quartz 8142ROSE QUARTZProfessional Complementary Health Formulas898cd57d-8656-457d-92ff-5b4ea13578002026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Difficulty Breathing Drops 2171DIFFICULTY BREATHING DROPSProfessional Complementary Health Formulas30bab475-47dd-4261-b497-1f8edf9dd4112026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Spleen/Pancreas 7002RET SPLEEN/PANCREASProfessional Complementary Health Formulasc6c82d50-0650-4cd9-85b9-c3cd422a35ce2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Vaccinosis Nosode 4004VACCINOSIS NOSODEProfessional Complementary Health Formulasdff675b3-6330-45d0-984c-526a8f44202b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Sinusitis Drops 2060SINUSITIS DROPSProfessional Complementary Health Formulas00469764-e0ab-45cf-8e61-6bdc67d31e542026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Large Ring Combination 9302LARGE RING COMBINATIONProfessional Complementary Health Formulascced8a69-7bc0-42ad-b80a-58fc603bf7652026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Domestic Animals Nosode Combination 9407DOMESTIC ANIMALS NOSODE COMBINATIONProfessional Complementary Health Formulas222c28aa-e07b-4706-9fb5-585b190f1c5b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph Stim Liquescence 3016LYMPH STIM LIQUESCENCEProfessional Complementary Health Formulasd91939ea-e3dc-49b1-949a-6618a4c4ae0d2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Nitrogen Combination 9310NITROGEN COMBINATIONProfessional Complementary Health Formulas72a7c0f3-0a57-4aa8-8fe8-a3267b9acd532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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