Rizatriptan Benzoate

Product NDC
51991-355
11-digit product format
519910355
Labeler code
51991
Product ID
51991-355_d48d54bc-d3a2-47bb-8959-65f6837d1c33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA200482
Marketing category
ANDA
Marketing start
2012-12-31
Marketing end
2024-07-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-355-78EA - Each51991-355b60af14e-986e-4865-9a9b-5d42faae9be512013-02-13
51991-355-99EA - Each51991-355a2ecd789-b725-4f52-9502-969a39b735d512013-02-13

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSNe76ddcf1-32e5-4288-ac8e-36c4bb22910d5
314209rizatriptan 10 MG Oral TabletSCDe76ddcf1-32e5-4288-ac8e-36c4bb22910d5
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYe76ddcf1-32e5-4288-ac8e-36c4bb22910d5
314209rizatriptan benzoate 10 MG Oral TabletPSN2086f746-f921-1af1-e054-00144ff88e882
314209rizatriptan 10 MG Oral TabletSCD2086f746-f921-1af1-e054-00144ff88e882
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY2086f746-f921-1af1-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-355-785199103557818 BLISTER PACK in 1 CARTON (51991-355-78) > 6 TABLET in 1 BLISTER PACK (51991-355-99) 18 blister pack2012-12-310000-00-00NoNoCurrent