FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
69097-866
11-digit product format
690970866
Labeler code
69097
Product ID
69097-866_6ace7fac-e700-4a32-95ce-07ffbd0201ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA204339
Marketing category
ANDA
Marketing start
2016-07-22
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
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 BENZOATE10 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-866-17Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET66
69097-866-85Rizatriptan Benzoate3 in 1 CARTONTABLET36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-866-17EA - Each69097-86673268e2c-086c-49e2-86d5-c673ae56f67612016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-866RIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.]6Current NDC, Legacy NDC, 2 package rows20220114_f462a507-921c-41c2-93ba-36003b6e8914.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN32094145-be64-4f14-ace7-b29c9b051daf7
314209rizatriptan 10 MG Oral TabletSCD32094145-be64-4f14-ace7-b29c9b051daf7
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY32094145-be64-4f14-ace7-b29c9b051daf7
314209rizatriptan benzoate 10 MG Oral TabletPSNf462a507-921c-41c2-93ba-36003b6e89146
312840rizatriptan benzoate 5 MG Oral TabletPSNf462a507-921c-41c2-93ba-36003b6e89146
314209rizatriptan 10 MG Oral TabletSCDf462a507-921c-41c2-93ba-36003b6e89146
312840rizatriptan 5 MG Oral TabletSCDf462a507-921c-41c2-93ba-36003b6e89146
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYf462a507-921c-41c2-93ba-36003b6e89146
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSYf462a507-921c-41c2-93ba-36003b6e89146
314209rizatriptan benzoate 10 MG Oral TabletPSN6535f200-ffa3-4564-972c-3bdadcde4a9b5
314209rizatriptan 10 MG Oral TabletSCD6535f200-ffa3-4564-972c-3bdadcde4a9b5
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY6535f200-ffa3-4564-972c-3bdadcde4a9b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-866-17690970866176 TABLET in 1 BLISTER PACK (69097-866-17) 6 tablet2016-07-220000-00-00NoNoCurrent
69097-866-85690970866853 TABLET in 1 CARTON (69097-866-85) 3 tablet2016-07-220000-00-00NoNoCurrent