Rizatriptan Benzoate

Product NDC
53002-3713
11-digit product format
530023713
Labeler code
53002
Product ID
53002-3713_c0c84f7d-a535-4b49-ab86-b372c18abfbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA203269
Marketing category
ANDA
Marketing start
2012-06-25
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
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3713-1Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET61
53002-3713-1Rizatriptan Benzoate3 in 1 CARTONTABLET31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3713RIZATRIPTAN BENZOATE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20220331_700d2061-dfe8-4352-9b83-befef21e3f35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN700d2061-dfe8-4352-9b83-befef21e3f351
314209rizatriptan 10 MG Oral TabletSCD700d2061-dfe8-4352-9b83-befef21e3f351
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY700d2061-dfe8-4352-9b83-befef21e3f351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3713-1530023713013 BLISTER PACK in 1 CARTON (53002-3713-1) > 6 TABLET in 1 BLISTER PACK3 blister pack2021-01-010000-00-00NoNoCurrent