FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
69097-865
11-digit product format
690970865
Labeler code
69097
Product ID
69097-865_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
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
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
69097-865-17Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET66
69097-865-85Rizatriptan Benzoate3 in 1 CARTONTABLET36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-865-17EA - Each69097-8651d8cf910-c01e-481c-8356-b795226016e812016-09-02
69097-865-85EA - Each69097-865010ff2bc-db81-4488-8dd3-d12ec2ab94d612016-08-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-865RIZATRIPTAN 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 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
312840rizatriptan benzoate 5 MG Oral TabletPSN3ad0286c-3909-4f0c-8d74-0250a08a22f34
312840rizatriptan 5 MG Oral TabletSCD3ad0286c-3909-4f0c-8d74-0250a08a22f34
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY3ad0286c-3909-4f0c-8d74-0250a08a22f34
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
69097-865-17690970865176 TABLET in 1 BLISTER PACK (69097-865-17) 6 tablet2016-07-220000-00-00NoNoCurrent
69097-865-85690970865853 TABLET in 1 CARTON (69097-865-85) 3 tablet2016-07-220000-00-00NoNoCurrent