FDA.reportPublic FDA data

NDC 0093-7471-19 - 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
0093-7471
Requested NDC
0093-7471-19
Package NDCs from labels
0093-7471-19, 0093-7471-43
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2019-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rizatriptan Benzoate - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2019-10-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7471-19Rizatriptan Benzoate1 in 1 BLISTER PACKTABLET18
0093-7471-43Rizatriptan Benzoate18 in 1 BOXTABLET188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7471RIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA, INC.]8Current NDC, Legacy NDC, 2 package rows20241114_4ef60c83-ba48-4134-968b-13800ea9b7f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7471-19EA - Each0093-7471e6fe05ba-b972-46a1-8d62-e489ed889fd812013-03-03
0093-7471-43EA - Each0093-7471e4144fec-8d7e-4eb6-ae23-c44cc25293d512013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [TEVA PHARMACEUTICALS USA INC]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 3 of 3 · 52 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
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
application number: ANDA077263
ndc (package): 0093-7471-19
ndc (package): 0093-7472-19
ndc (package): 0093-7472-43
ndc (package): 0093-7471-43
ndc (product): 0093-7471
ndc (product): 0093-7472
ndc11 (package): 00093747119
rxcui: 314209
rxcui: 312840
spl id: fe55c129-f82a-46c6-add0-e9f1d405eec6
spl set id: 4ef60c83-ba48-4134-968b-13800ea9b7f2
unii: WR978S7QHH

Reported adverse events (FAERS/openFDA)#

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