FDA.reportPublic FDA data

Rizatriptan

Product NDC
71335-1352
11-digit product format
713351352
Labeler code
71335
Product ID
71335-1352_9f140953-589f-43ab-b977-a5c48c5853c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203147
Marketing category
ANDA
Marketing start
2014-03-11
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui314209

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
71335-1352-1Rizatriptan10 in 1 BLISTER PACKTABLET, FILM COATED1010
71335-1352-2Rizatriptan6 in 1 BLISTER PACKTABLET, FILM COATED610
71335-1352-3Rizatriptan90 in 1 BLISTER PACKTABLET, FILM COATED9010
71335-1352-4Rizatriptan9 in 1 BLISTER PACKTABLET, FILM COATED910
71335-1352-5Rizatriptan30 in 1 BLISTER PACKTABLET, FILM COATED3010
71335-1352-6Rizatriptan18 in 1 BLISTER PACKTABLET, FILM COATED1810
71335-1352-7Rizatriptan12 in 1 BLISTER PACKTABLET, FILM COATED1210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1352-4EA - Each71335-1352a6126f1f-57a8-4a97-b085-2b1ca3de449312020-01-03
71335-1352-6EA - Each71335-1352bc25610b-c8bb-4615-ab4e-4c3101892fc212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1352RIZATRIPTAN TABLET, FILM COATED [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 7 package rows20240830_7db81532-6781-47f7-a5cd-6aeda9b8bf6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN7db81532-6781-47f7-a5cd-6aeda9b8bf6f10
314209rizatriptan 10 MG Oral TabletSCD7db81532-6781-47f7-a5cd-6aeda9b8bf6f10
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY7db81532-6781-47f7-a5cd-6aeda9b8bf6f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1352-17133513520110 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-1) 2022-09-190000-00-00NoNoCurrent
71335-1352-2713351352026 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-2) 2021-03-080000-00-00NoNoCurrent
71335-1352-37133513520390 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-3) 2022-09-190000-00-00NoNoCurrent
71335-1352-4713351352049 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-4) 2019-10-010000-00-00NoNoCurrent
71335-1352-57133513520530 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-5) 2021-09-030000-00-00NoNoCurrent
71335-1352-67133513520618 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-6) 2019-10-110000-00-00NoNoCurrent
71335-1352-77133513520712 TABLET, FILM COATED in 1 BLISTER PACK (71335-1352-7) 2020-01-090000-00-00NoNoCurrent