FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
71335-1912
11-digit product format
713351912
Labeler code
71335
Product ID
71335-1912_31217a32-abec-47de-b4ec-bf2205931ffb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202490
Marketing category
ANDA
Marketing start
2012-12-31
Substance
RIZATRIPTAN BENZOATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rizatriptan Benzoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui314209

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
707ffe6e-db52-42b0-9a65-a0c00213f04fProduct name120231006
8b537454-32b8-7e64-1395-258682782d07Product name520170424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1912-1Rizatriptan Benzoate10 in 1 BLISTER PACKTABLET10103
71335-1912-2Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET6103
71335-1912-3Rizatriptan Benzoate90 in 1 BLISTER PACKTABLET90103
71335-1912-4Rizatriptan Benzoate9 in 1 BLISTER PACKTABLET9103
71335-1912-5Rizatriptan Benzoate30 in 1 BLISTER PACKTABLET30103
71335-1912-6Rizatriptan Benzoate18 in 1 BLISTER PACKTABLET18103
71335-1912-7Rizatriptan Benzoate12 in 1 BLISTER PACKTABLET12103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1912RIZATRIPTAN BENZOATE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 7 package rows20240509_03b5a887-d689-48a6-bd41-ae1ab4ae4990.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN03b5a887-d689-48a6-bd41-ae1ab4ae4990103
314209rizatriptan 10 MG Oral TabletSCD03b5a887-d689-48a6-bd41-ae1ab4ae4990103
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY03b5a887-d689-48a6-bd41-ae1ab4ae4990103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1912-17133519120110 TABLET in 1 BLISTER PACK (71335-1912-1) 10 tablet2022-02-140000-00-00NoNoCurrent
71335-1912-2713351912026 TABLET in 1 BLISTER PACK (71335-1912-2) 6 tablet2022-02-140000-00-00NoNoCurrent
71335-1912-37133519120390 TABLET in 1 BLISTER PACK (71335-1912-3) 90 tablet2022-02-140000-00-00NoNoCurrent
71335-1912-4713351912049 TABLET in 1 BLISTER PACK (71335-1912-4) 9 tablet2022-02-140000-00-00NoNoCurrent
71335-1912-57133519120530 TABLET in 1 BLISTER PACK (71335-1912-5) 30 tablet2022-02-140000-00-00NoNoCurrent
71335-1912-67133519120618 TABLET in 1 BLISTER PACK (71335-1912-6) 18 tablet2022-02-140000-00-00NoNoCurrent
71335-1912-77133519120712 TABLET in 1 BLISTER PACK (71335-1912-7) 12 tablet2022-02-140000-00-00NoNoCurrent