Rizatriptan Benzoate

Product NDC
29300-316
11-digit product format
293000316
Labeler code
29300
Product ID
29300-316_b86514bb-961e-4cf9-9f52-d5f441b7c97f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA207836
Marketing category
ANDA
Marketing start
2017-03-07
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
29300-316-21Rizatriptan Benzoate4 in 1 CARTONTABLET48
29300-316-31Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET38
29300-316-81Rizatriptan Benzoate6 in 1 CARTONTABLET68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-316-21EA - Each29300-316d84c98e7-67a2-46d1-9e4b-41b05fc3c5af12018-12-13
29300-316-31EA - Each29300-316f53ac481-df5e-411d-b551-be59d07740b812018-12-13
29300-316-81EA - Each29300-31656d903c5-9ad9-42f8-8111-8e529fd8b2fb12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-316RIZATRIPTAN BENZOATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]8Current NDC, Legacy NDC, 3 package rows20221129_35f26d3c-268b-4114-9b5b-1c2e0b9ddfd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN35f26d3c-268b-4114-9b5b-1c2e0b9ddfd58
312840rizatriptan benzoate 5 MG Oral TabletPSN35f26d3c-268b-4114-9b5b-1c2e0b9ddfd58
314209rizatriptan 10 MG Oral TabletSCD35f26d3c-268b-4114-9b5b-1c2e0b9ddfd58
312840rizatriptan 5 MG Oral TabletSCD35f26d3c-268b-4114-9b5b-1c2e0b9ddfd58
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY35f26d3c-268b-4114-9b5b-1c2e0b9ddfd58
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY35f26d3c-268b-4114-9b5b-1c2e0b9ddfd58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-316-21293000316214 BLISTER PACK in 1 CARTON (29300-316-21) / 3 TABLET in 1 BLISTER PACK (29300-316-31) 4 blister pack2017-07-050000-00-00NoNoCurrent
29300-316-31293000316313 in 1 BLISTER PACKHistorical
29300-316-81293000316816 BLISTER PACK in 1 CARTON (29300-316-81) / 3 TABLET in 1 BLISTER PACK (29300-316-31) 6 blister pack2017-07-050000-00-00NoNoCurrent