RIZATRIPTAN Benzoate

Product NDC
51991-363
11-digit product format
519910363
Labeler code
51991
Product ID
51991-363_24ffdbe7-4f42-4277-942a-9edd765df282
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIZATRIPTAN Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA203478
Marketing category
ANDA
Marketing start
2013-07-01
Marketing end
0000-00-00
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
2021-12-31
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-363-78EA - Each51991-363f02beeff-1e5f-4d6a-841f-675e4258f83412013-08-02
51991-363-99EA - Each51991-363a8a82ad7-25f8-4aa7-a121-e1344533a8ca12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
GLYCINEINACTIVE INGREDIENTTE7660XO1CRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
MONOSODIUM CITRATEINACTIVE INGREDIENT68538UP9SERIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-363RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [BRECKENRIDGE PHARMACEUTICAL, INC.]10Legacy NDC20240327_cd03ee57-0fb8-4ddf-88e8-b1f953a593f8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-363-78519910363783 BLISTER PACK in 1 CARTON (51991-363-78) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51991-363-99) 3 blister pack2013-07-010000-00-00NoNoCurrent