FDA.reportPublic FDA data

RIZATRIPTAN BENZOATE

Product NDC
61919-394
11-digit product format
619190394
Labeler code
61919
Product ID
61919-394_4d3a8187-effc-938f-e063-6294a90a86b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIZATRIPTAN BENZOATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA204339
Marketing category
ANDA
Marketing start
2018-03-12
Substance
RIZATRIPTAN BENZOATE
Active strength
5 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RIZATRIPTAN BENZOATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui312840, 314209

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
61919-394-182025-01-30C16284748780-12cef2736-59cc-d83d-e063-dadaa90ab31fRIZATRIPTAN BENZOATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-394-18RIZATRIPTAN BENZOATE18 in 1 BLISTER PACKTABLET183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-394-18EA - Each61919-394e999834e-c485-493e-8715-37a229ddc77512018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-394RIZATRIPTAN BENZOATE TABLET [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20190423_673d584c-0691-d2fb-e053-2991aa0a7797.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN673d584c-0691-d2fb-e053-2991aa0a77973
312840rizatriptan benzoate 5 MG Oral TabletPSN673d584c-0691-d2fb-e053-2991aa0a77973
314209rizatriptan 10 MG Oral TabletSCD673d584c-0691-d2fb-e053-2991aa0a77973
312840rizatriptan 5 MG Oral TabletSCD673d584c-0691-d2fb-e053-2991aa0a77973
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY673d584c-0691-d2fb-e053-2991aa0a77973
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY673d584c-0691-d2fb-e053-2991aa0a77973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-394-186191903941818 TABLET in 1 BLISTER PACK (61919-394-18) 18 tablet2018-03-120000-00-00NoNoCurrent