FDA.reportPublic FDA data

RIZATRIPTAN BENZOATE

Product NDC
69452-156
11-digit product format
694520156
Labeler code
69452
Product ID
69452-156_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
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204722-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2017-01-11
A204722-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2017-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A204722-001AB
A204722-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204722-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2017-01-11a50c72e98297…
2026-08-01 22:54:322026-06A204722-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALAB2017-01-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204722-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204722-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEPanacea Biotec Limited9c70370d-72ac-e062-e25c-97d57e6397ab2024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204722
application number: ANDA204722
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEBionpharma Inc.,91e160d6-f23f-e5e0-baec-908b2d25ce3c2021-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204722
application number: ANDA204722
ndc (product): 69452-156

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WR978S7QHHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312837Internal RxNorm lookup
312839Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91e160d6-f23f-e5e0-baec-908b2d25ce3cAvailable on FDA.report

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
69452-156-73RIZATRIPTAN BENZOATE6 in 1 CARTONTABLET, ORALLY DISINTEGRATING65
69452-156-74RIZATRIPTAN BENZOATE3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-156-73EA - Each69452-1561b280876-f6f4-41d9-9aab-228bd8b2725012017-06-15
69452-156-74EA - Each69452-156e06e9260-7898-4f36-b665-0b71a9c016d412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-156RIZATRIPTAN 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-156-73694520156736 BLISTER PACK in 1 CARTON (69452-156-73) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (69452-156-74) 6 blister pack2017-01-170000-00-00NoNoCurrent
69452-156-74694520156743 in 1 BLISTER PACKHistorical