FDA.reportPublic FDA data

MAXALT-MLT

Product NDC
0006-3801
11-digit product format
000063801
Labeler code
0006
Product ID
0006-3801_27f96f39-58fb-422e-ba80-be074e98fc07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Merck Sharp & Dohme Corp.
Application
NDA020865
Marketing category
NDA
Marketing start
1998-06-29
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
2022-12-31
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b537454-32b8-7e64-1395-258682782d07Product name520170424
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3801-01EA - Each0006-3801f2e795c7-05e4-4ce9-bf98-5684084daac112012-07-24
0006-3801-12EA - Each0006-3801349d83a8-c098-4f11-8dce-455eb7b497b412012-07-24
0006-3801-18EA - Each0006-380171e12342-334a-4d18-b8bd-bda45e9e60e112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
rizatriptan benzoateACTIVE INGREDIENTWR978S7QHHMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
rizatriptanACTIVE MOIETY51086HBW8GMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
aspartameINACTIVE INGREDIENTZ0H242BBR1MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
glycineINACTIVE INGREDIENTTE7660XO1CMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36AMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213322Maxalt 10 MG Oral TabletPSN3756d8e3-7e89-46c7-8723-6fea653639132
828537Maxalt-MLT 10 MG Disintegrating Oral TabletPSN3756d8e3-7e89-46c7-8723-6fea653639132
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN3756d8e3-7e89-46c7-8723-6fea653639132
314209rizatriptan benzoate 10 MG Oral TabletPSN3756d8e3-7e89-46c7-8723-6fea653639132
828537rizatriptan 10 MG Disintegrating Oral Tablet [Maxalt]SBD3756d8e3-7e89-46c7-8723-6fea653639132
213322rizatriptan 10 MG Oral Tablet [Maxalt]SBD3756d8e3-7e89-46c7-8723-6fea653639132
312837rizatriptan 10 MG Disintegrating Oral TabletSCD3756d8e3-7e89-46c7-8723-6fea653639132
314209rizatriptan 10 MG Oral TabletSCD3756d8e3-7e89-46c7-8723-6fea653639132
828537Maxalt 10 MG Disintegrating Oral TabletSY3756d8e3-7e89-46c7-8723-6fea653639132
213322Maxalt 10 MG Oral TabletSY3756d8e3-7e89-46c7-8723-6fea653639132
828537Maxalt-MLT 10 MG Disintegrating Oral TabletSY3756d8e3-7e89-46c7-8723-6fea653639132
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY3756d8e3-7e89-46c7-8723-6fea653639132
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY3756d8e3-7e89-46c7-8723-6fea653639132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-3801-18000063801186 CONTAINER in 1 CARTON (0006-3801-18) > 3 POUCH in 1 CONTAINER > 1 BLISTER PACK in 1 POUCH (0006-3801-01) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 container1998-06-290000-00-00NoNoCurrent