FDA.reportPublic FDA data

MAXALT

Product NDC
21695-956
11-digit product format
216950956
Labeler code
21695
Product ID
21695-956_3f30e6a5-f3c0-4c20-b1a2-142575eb0e24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors 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
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-956-182019-09-24C16284748780-1934fe258-4d5e-48b1-e053-8cdaa90a720aMAXALT ® (RIZATRIPTAN BENZOATE) TABLETS MAXALT-MLT ® (RIZATRIPTAN BENZOATE) ORALLY DISINTEGRATING TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-956-18MAXALT18 in 1 CARTONTABLET181
21695-956-18MAXALT1 in 1 POUCHTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-956-18EA - Each21695-9563648cddb-8ede-419d-9126-07c88d45565e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-956MAXALT (RIZATRIPTAN BENZOATE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110914_3f30e6a5-f3c0-4c20-b1a2-142575eb0e24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
21695-956-182169509561818 in 1 CARTONHistorical