FDA.reportPublic FDA data

RIZATRIPTAN BENZOATE

Product NDC
69452-157
11-digit product format
694520157
Labeler code
69452
Product ID
69452-157_bc889905-a174-9524-e053-2995a90a679c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bionpharma Inc.,
Application
ANDA204722
Marketing category
ANDA
Marketing start
2017-01-17
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
Rxcui312837, 312839

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
69452-157-73RIZATRIPTAN BENZOATE6 in 1 CARTONTABLET, ORALLY DISINTEGRATING65
69452-157-74RIZATRIPTAN BENZOATE3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-157-73EA - Each69452-15758fe028e-5c18-468e-9bc1-e319528679a912017-06-15
69452-157-74EA - Each69452-15776a4f573-ab5c-4d56-8caf-3a8e63bb745a12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-157RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [BIONPHARMA INC.,]5Current NDC, Legacy NDC, 2 package rows20210303_91e160d6-f23f-e5e0-baec-908b2d25ce3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN91e160d6-f23f-e5e0-baec-908b2d25ce3c5
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN91e160d6-f23f-e5e0-baec-908b2d25ce3c5
312837rizatriptan 10 MG Disintegrating Oral TabletSCD91e160d6-f23f-e5e0-baec-908b2d25ce3c5
312839rizatriptan 5 MG Disintegrating Oral TabletSCD91e160d6-f23f-e5e0-baec-908b2d25ce3c5
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY91e160d6-f23f-e5e0-baec-908b2d25ce3c5
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY91e160d6-f23f-e5e0-baec-908b2d25ce3c5
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN8455360f-3b3f-4101-ad1b-0ca3fc7e45e43
312837rizatriptan 10 MG Disintegrating Oral TabletSCD8455360f-3b3f-4101-ad1b-0ca3fc7e45e43
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY8455360f-3b3f-4101-ad1b-0ca3fc7e45e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-157-73694520157736 BLISTER PACK in 1 CARTON (69452-157-73) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (69452-157-74) 6 blister pack2017-01-170000-00-00NoNoCurrent
69452-157-74694520157743 in 1 BLISTER PACKHistorical