Rizatriptan Benzoate

Product NDC
0378-1403
11-digit product format
003781403
Labeler code
0378
Product ID
0378-1403_884b2f91-8db1-4ea6-9332-acbae2ef2191
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA201993
Marketing category
ANDA
Marketing start
2012-12-31
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1403-96EA - Each0378-1403339faf3f-22f8-49fa-ae16-1214ec173a4c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]4
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1403RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]8Legacy NDC20250101_30a602e9-495e-43ae-a4ea-acb564540b25.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1403-960037814039612 TABLET in 1 BOTTLE, PLASTIC (0378-1403-96) 12 tablet2012-12-310000-00-00NoNoCurrent