RIZATRIPTAN BENZOATE

Product NDC
82619-112
11-digit product format
826190112
Labeler code
82619
Product ID
82619-112_40b947bf-a78e-6681-e063-6294a90ad145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Creekwood Pharmaceuticals LLC
Application
ANDA202047
Marketing category
ANDA
Marketing start
2012-12-31
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
A202047-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31
A202047-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202047-001AB
A202047-002AB

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 UTC2026-02A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202047-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2012-12-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A202047-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2012-12-31782e0a99824c…

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 UTC2026-02A202047-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202047-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202047-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202047-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202047-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202047-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202047-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202047-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202047-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202047-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202047-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202047-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202047-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202047-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202047-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202047-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202047-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202047-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202047-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202047-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202047-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202047-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202047-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202047-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202047-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202047-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202047-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202047-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202047-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202047-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202047-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202047-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202047-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202047-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202047-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202047-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202047-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202047-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202047-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202047-002AB1782e0a99824c…

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 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
312840Internal RxNorm lookup
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
b517896b-167e-47d5-801d-7458f80e8ee2Available 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
82619-112-01RIZATRIPTAN BENZOATE30 in 1 BOTTLETABLET303
82619-112-02RIZATRIPTAN BENZOATE1000 in 1 BOTTLETABLET10003
82619-112-04RIZATRIPTAN BENZOATE2 in 1 CARTONTABLET23
82619-112-04RIZATRIPTAN BENZOATE6 in 1 BLISTER PACKTABLET63
82619-112-05RIZATRIPTAN BENZOATE6 in 1 BLISTER PACKTABLET63
82619-112-05RIZATRIPTAN BENZOATE3 in 1 CARTONTABLET33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82619-112-04EA - Each82619-11216fd0e88-d9fa-4ffc-b0f9-a0c2604ec70812023-10-16
82619-112-05EA - Each82619-1124c735f35-4812-49b8-bf84-41ab4bcac9ef12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82619-112RIZATRIPTAN BENZOATE TABLET [CREEKWOOD PHARMACEUTICALS LLC]2Current NDC, 6 package rows20241016_b517896b-167e-47d5-801d-7458f80e8ee2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATECreekwood Pharmaceuticals LLCb517896b-167e-47d5-801d-7458f80e8ee22025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202047
application number: ANDA202047
ndc (product): 82619-112

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSNb517896b-167e-47d5-801d-7458f80e8ee23
312840rizatriptan benzoate 5 MG Oral TabletPSNb517896b-167e-47d5-801d-7458f80e8ee23
314209rizatriptan 10 MG Oral TabletSCDb517896b-167e-47d5-801d-7458f80e8ee23
312840rizatriptan 5 MG Oral TabletSCDb517896b-167e-47d5-801d-7458f80e8ee23
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYb517896b-167e-47d5-801d-7458f80e8ee23
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSYb517896b-167e-47d5-801d-7458f80e8ee23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82619-112-018261901120130 TABLET in 1 BOTTLE (82619-112-01) 30 tablet2023-09-15NoNoCurrent
82619-112-02826190112021000 TABLET in 1 BOTTLE (82619-112-02) 1000 tablet2023-09-15NoNoCurrent
82619-112-04826190112042 BLISTER PACK in 1 CARTON (82619-112-04) / 6 TABLET in 1 BLISTER PACK2 blister pack2023-09-15NoNoCurrent
82619-112-05826190112053 BLISTER PACK in 1 CARTON (82619-112-05) / 6 TABLET in 1 BLISTER PACK3 blister pack2023-09-15NoNoCurrent