FDA.reportPublic FDA data

MAXALT

Product NDC
0006-0267
11-digit product format
000060267
Labeler code
0006
Product ID
0006-0267_27f96f39-58fb-422e-ba80-be074e98fc07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Merck Sharp & Dohme Corp.
Application
NDA020864
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
0006-0267-01EA - Each0006-026784a88051-567a-40ec-b1be-1df2a4011f1912015-05-05
0006-0267-18EA - Each0006-0267832410d8-2c3b-4fea-bbbf-461c521ec09d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHMAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
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
RIZATRIPTANACTIVE MOIETY51086HBW8GMAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
aspartameINACTIVE INGREDIENTZ0H242BBR1MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LMAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
gelatinINACTIVE INGREDIENT2G86QN327LMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
GLYCINEINACTIVE INGREDIENTTE7660XO1CMAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
glycineINACTIVE INGREDIENTTE7660XO1CMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AMAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
mannitolINACTIVE INGREDIENT3OWL53L36AMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING MAXALT (RIZATRIPTAN BENZOATE) TABLET [STAT RX USA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
rizatriptan benzoateACTIVE INGREDIENTWR978S7QHHMAXALT (RIZATRIPTAN BENZOATE) TABLET [REBEL DISTRIBUTORS CORP]1
rizatriptanACTIVE MOIETY51086HBW8GMAXALT (RIZATRIPTAN BENZOATE) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMAXALT (RIZATRIPTAN BENZOATE) TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MAXALT (RIZATRIPTAN BENZOATE) TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMAXALT (RIZATRIPTAN BENZOATE) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MAXALT (RIZATRIPTAN BENZOATE) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMAXALT (RIZATRIPTAN BENZOATE) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213322Maxalt 10 MG Oral TabletPSN08d06e6f-a1d8-4bd9-b851-d63858d55f912
213322Maxalt 10 MG Oral TabletPSN3756d8e3-7e89-46c7-8723-6fea653639132
828537Maxalt-MLT 10 MG Disintegrating Oral TabletPSN3756d8e3-7e89-46c7-8723-6fea653639132
828536Maxalt-MLT 5 MG Disintegrating Oral TabletPSN08d06e6f-a1d8-4bd9-b851-d63858d55f912
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN3756d8e3-7e89-46c7-8723-6fea653639132
314209rizatriptan benzoate 10 MG Oral TabletPSN3756d8e3-7e89-46c7-8723-6fea653639132
314209rizatriptan benzoate 10 MG Oral TabletPSN08d06e6f-a1d8-4bd9-b851-d63858d55f912
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN08d06e6f-a1d8-4bd9-b851-d63858d55f912
828537rizatriptan 10 MG Disintegrating Oral Tablet [Maxalt]SBD3756d8e3-7e89-46c7-8723-6fea653639132
213322rizatriptan 10 MG Oral Tablet [Maxalt]SBD08d06e6f-a1d8-4bd9-b851-d63858d55f912
213322rizatriptan 10 MG Oral Tablet [Maxalt]SBD3756d8e3-7e89-46c7-8723-6fea653639132
828536rizatriptan 5 MG Disintegrating Oral Tablet [Maxalt]SBD08d06e6f-a1d8-4bd9-b851-d63858d55f912
312837rizatriptan 10 MG Disintegrating Oral TabletSCD3756d8e3-7e89-46c7-8723-6fea653639132
314209rizatriptan 10 MG Oral TabletSCD08d06e6f-a1d8-4bd9-b851-d63858d55f912
314209rizatriptan 10 MG Oral TabletSCD3756d8e3-7e89-46c7-8723-6fea653639132
312839rizatriptan 5 MG Disintegrating Oral TabletSCD08d06e6f-a1d8-4bd9-b851-d63858d55f912
828537Maxalt 10 MG Disintegrating Oral TabletSY3756d8e3-7e89-46c7-8723-6fea653639132
213322Maxalt 10 MG Oral TabletSY08d06e6f-a1d8-4bd9-b851-d63858d55f912
213322Maxalt 10 MG Oral TabletSY3756d8e3-7e89-46c7-8723-6fea653639132
828536Maxalt 5 MG Disintegrating Oral TabletSY08d06e6f-a1d8-4bd9-b851-d63858d55f912
828537Maxalt-MLT 10 MG Disintegrating Oral TabletSY3756d8e3-7e89-46c7-8723-6fea653639132
828536Maxalt-MLT 5 MG Disintegrating Oral TabletSY08d06e6f-a1d8-4bd9-b851-d63858d55f912
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 TabletSY08d06e6f-a1d8-4bd9-b851-d63858d55f912
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY3756d8e3-7e89-46c7-8723-6fea653639132
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY08d06e6f-a1d8-4bd9-b851-d63858d55f912
213322Maxalt 10 MG Oral TabletPSN3f30e6a5-f3c0-4c20-b1a2-142575eb0e241
314209rizatriptan benzoate 10 MG Oral TabletPSN3f30e6a5-f3c0-4c20-b1a2-142575eb0e241
213322rizatriptan 10 MG Oral Tablet [Maxalt]SBD3f30e6a5-f3c0-4c20-b1a2-142575eb0e241
314209rizatriptan 10 MG Oral TabletSCD3f30e6a5-f3c0-4c20-b1a2-142575eb0e241
213322Maxalt 10 MG Oral TabletSY3f30e6a5-f3c0-4c20-b1a2-142575eb0e241
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY3f30e6a5-f3c0-4c20-b1a2-142575eb0e241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-0267-180000602671818 POUCH in 1 CARTON (0006-0267-18) > 1 TABLET in 1 POUCH (0006-0267-01) 18 pouch1998-06-290000-00-00NoNoCurrent