FDA.reportPublic FDA data

RIZATRIPTAN BENZOATE

Product NDC
43817-133
11-digit product format
438170133
Labeler code
43817
Product ID
43817-133_28d0cbcc-59cc-7cf4-e063-6294a90a9b53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Panacea Biotec Limited
Application
ANDA204722
Marketing category
ANDA
Marketing start
2017-01-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RIZATRIPTAN BENZOATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui312837, 312839

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43817-133-03RIZATRIPTAN BENZOATE3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING38
43817-133-04RIZATRIPTAN BENZOATE6 in 1 CARTONTABLET, ORALLY DISINTEGRATING68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43817-133RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PANACEA BIOTEC LIMITED]8Current NDC, Legacy NDC, 2 package rows20241210_9c70370d-72ac-e062-e25c-97d57e6397ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN9c70370d-72ac-e062-e25c-97d57e6397ab8
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN9c70370d-72ac-e062-e25c-97d57e6397ab8
312837rizatriptan 10 MG Disintegrating Oral TabletSCD9c70370d-72ac-e062-e25c-97d57e6397ab8
312839rizatriptan 5 MG Disintegrating Oral TabletSCD9c70370d-72ac-e062-e25c-97d57e6397ab8
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY9c70370d-72ac-e062-e25c-97d57e6397ab8
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY9c70370d-72ac-e062-e25c-97d57e6397ab8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43817-133-03438170133033 in 1 BLISTER PACKHistorical
43817-133-04438170133046 BLISTER PACK in 1 CARTON (43817-133-04) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (43817-133-03) 6 blister pack2017-01-170000-00-00NoNoCurrent