FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
29300-268
11-digit product format
293000268
Labeler code
29300
Product ID
29300-268_69ca309f-1132-40c9-b250-665c360968e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA207835
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
Rxcui312837, 312839

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
707ffe6e-db52-42b0-9a65-a0c00213f04fProduct name120231006
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b537454-32b8-7e64-1395-258682782d07Product name520170424
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-268-21Rizatriptan Benzoate4 in 1 CARTONTABLET, ORALLY DISINTEGRATING46
29300-268-31Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING36
29300-268-81Rizatriptan Benzoate6 in 1 CARTONTABLET, ORALLY DISINTEGRATING66
29300-268-91Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-268-31EA - Each29300-26832d51f4a-5bd8-4d39-831d-bf5148e9af5d12019-10-07
29300-268-81EA - Each29300-268c633c0b7-6b43-4304-ae51-854721069f7312019-10-07
29300-268-91EA - Each29300-268a65b6df7-8b4d-476f-82b2-9edb6acf195512019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-268RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [UNICHEM PHARMACEUTICALS (USA), INC.]6Current NDC, Legacy NDC, 4 package rows20200512_3cdeccf6-36dd-4a9e-9687-2f7cce47af5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN3cdeccf6-36dd-4a9e-9687-2f7cce47af5f6
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN3cdeccf6-36dd-4a9e-9687-2f7cce47af5f6
312837rizatriptan 10 MG Disintegrating Oral TabletSCD3cdeccf6-36dd-4a9e-9687-2f7cce47af5f6
312839rizatriptan 5 MG Disintegrating Oral TabletSCD3cdeccf6-36dd-4a9e-9687-2f7cce47af5f6
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY3cdeccf6-36dd-4a9e-9687-2f7cce47af5f6
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY3cdeccf6-36dd-4a9e-9687-2f7cce47af5f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-268-21293000268214 BLISTER PACK in 1 CARTON (29300-268-21) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-268-31) 4 blister pack2017-07-050000-00-00NoNoCurrent
29300-268-31293000268313 in 1 BLISTER PACKHistorical
29300-268-81293000268816 BLISTER PACK in 1 CARTON (29300-268-81) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-268-31) 6 blister pack2017-07-050000-00-00NoNoCurrent
29300-268-91293000268913 BLISTER PACK in 1 CARTON (29300-268-91) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-268-31) 3 blister pack2017-07-050000-00-00NoNoCurrent