FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
57237-085
11-digit product format
572370085
Labeler code
57237
Product ID
57237-085_e693bf18-c909-41c8-bfd5-21cb4458b925
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA203062
Marketing category
ANDA
Marketing start
2013-07-01
Substance
RIZATRIPTAN BENZOATE
Active strength
5 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 BENZOATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui312837, 312839

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
707ffe6e-db52-42b0-9a65-a0c00213f04fProduct name120231006
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b537454-32b8-7e64-1395-258682782d07Product name520170424
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-085-63Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING310
57237-085-63Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-085-63EA - Each57237-085b4ad63f0-2d48-4e52-82ae-dfe42c2230dd12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-085RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 2 package rows20240222_2337e102-8df0-4e7f-81d8-5cb86cd48674.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN2337e102-8df0-4e7f-81d8-5cb86cd4867410
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN2337e102-8df0-4e7f-81d8-5cb86cd4867410
312837rizatriptan 10 MG Disintegrating Oral TabletSCD2337e102-8df0-4e7f-81d8-5cb86cd4867410
312839rizatriptan 5 MG Disintegrating Oral TabletSCD2337e102-8df0-4e7f-81d8-5cb86cd4867410
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY2337e102-8df0-4e7f-81d8-5cb86cd4867410
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY2337e102-8df0-4e7f-81d8-5cb86cd4867410
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN8fa794f4-4253-485d-b4ee-9861780313391
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN8fa794f4-4253-485d-b4ee-9861780313391
312837rizatriptan 10 MG Disintegrating Oral TabletSCD8fa794f4-4253-485d-b4ee-9861780313391
312839rizatriptan 5 MG Disintegrating Oral TabletSCD8fa794f4-4253-485d-b4ee-9861780313391
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY8fa794f4-4253-485d-b4ee-9861780313391
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY8fa794f4-4253-485d-b4ee-9861780313391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-085-63572370085633 BLISTER PACK in 1 CARTON (57237-085-63) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2013-07-010000-00-00NoNoCurrent