FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
57237-087
11-digit product format
572370087
Labeler code
57237
Product ID
57237-087_1bef187c-7644-4b06-b4cb-f73499d65bdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202490
Marketing category
ANDA
Marketing start
2012-12-31
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
Rxcui312840, 314209

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
57237-087-34Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET310
57237-087-34Rizatriptan Benzoate4 in 1 CARTONTABLET410
57237-087-63Rizatriptan Benzoate3 in 1 CARTONTABLET310
57237-087-63Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-087-34EA - Each57237-087f115c5f7-52bb-44c6-a7e9-77baa323a88c12016-10-06
57237-087-63EA - Each57237-08740853ab9-2809-4dcd-b775-7c586feed0a212016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [CITRON PHARMA LLC]1
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [CITRON PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [CITRON PHARMA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN BENZOATE TABLET [CITRON PHARMA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [CITRON PHARMA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-087RIZATRIPTAN BENZOATE TABLET [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 4 package rows20240222_222f77ff-d3f7-40f9-989c-e5902f44ef1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN222f77ff-d3f7-40f9-989c-e5902f44ef1e10
312840rizatriptan benzoate 5 MG Oral TabletPSN222f77ff-d3f7-40f9-989c-e5902f44ef1e10
314209rizatriptan 10 MG Oral TabletSCD222f77ff-d3f7-40f9-989c-e5902f44ef1e10
312840rizatriptan 5 MG Oral TabletSCD222f77ff-d3f7-40f9-989c-e5902f44ef1e10
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY222f77ff-d3f7-40f9-989c-e5902f44ef1e10
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY222f77ff-d3f7-40f9-989c-e5902f44ef1e10
312840rizatriptan benzoate 5 MG Oral TabletPSN01762e5f-db9a-49b3-8da1-60967970a3184
312840rizatriptan 5 MG Oral TabletSCD01762e5f-db9a-49b3-8da1-60967970a3184
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY01762e5f-db9a-49b3-8da1-60967970a3184
312840rizatriptan benzoate 5 MG Oral TabletPSN05150193-cc2f-8b41-e063-6394a90a184c3
312840rizatriptan 5 MG Oral TabletSCD05150193-cc2f-8b41-e063-6394a90a184c3
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY05150193-cc2f-8b41-e063-6394a90a184c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-087-34572370087344 BLISTER PACK in 1 CARTON (57237-087-34) / 3 TABLET in 1 BLISTER PACK4 blister pack2012-12-310000-00-00NoNoCurrent
57237-087-63572370087633 BLISTER PACK in 1 CARTON (57237-087-63) / 6 TABLET in 1 BLISTER PACK3 blister pack2012-12-310000-00-00NoNoCurrent