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

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
A203147-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-11
A203147-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203147-001AB
A203147-002AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203147-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-02-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A203147-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-02-11782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203147-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203147-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203147-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203147-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203147-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203147-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203147-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203147-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203147-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203147-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203147-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203147-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203147-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203147-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203147-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203147-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203147-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203147-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203147-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203147-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203147-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203147-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203147-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203147-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203147-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203147-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203147-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203147-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203147-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203147-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203147-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203147-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203147-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203147-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203147-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203147-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203147-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203147-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203147-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203147-002AB1782e0a99824c…

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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314209Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7db81532-6781-47f7-a5cd-6aeda9b8bf6fAvailable 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
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rizatriptan BenzoateRIZATRIPTAN BENZOATEDirect_Rxf754388d-77f1-0d8d-e053-6394a90a7b7e2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203147
application number: ANDA203147
RizatriptanRIZATRIPTANBryant Ranch Prepackf000d96c-42a0-4aac-96ca-8cef289979ce2025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203147
application number: ANDA203147
RizatriptanRIZATRIPTANA-S Medication Solutions34395ed2-97b7-4220-9089-0e90169d30832025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203147
application number: ANDA203147
RizatriptanRIZATRIPTANBryant Ranch Prepack7db81532-6781-47f7-a5cd-6aeda9b8bf6f2024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203147
application number: ANDA203147
ndc (product): 71335-1352
RizatriptanRIZATRIPTANMacleods Pharmaceuticals Limited27bc2cfc-fefb-4b50-a0dc-6268c69b49022022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203147
application number: ANDA203147

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