Rizatriptan benzoate

Product NDC
69097-181
11-digit product format
690970181
Labeler code
69097
Product ID
69097-181_9791dbbc-d90e-4c39-be0d-ea0723b7b7d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077526
Marketing category
ANDA
Marketing start
2013-03-26
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69097-181DDiscontinued by firm2026-08-07
excluded packagepackage69097-18169097-181-65DDiscontinued by firm2026-08-07
excluded packagepackage69097-18169097-181-66DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69097-181-66d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69097-181-65d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-181-66f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-181-65f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-181-662ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-181-652ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-181-66a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-181-65a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-181-66cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-181-65cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-181-66cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-181-65cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-181-66302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-181-65302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-181-66ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-181-65ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-181-660efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-181-650efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-181-66ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-181-65ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-181-66367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-181-65367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-181-66557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-181-65557ba5c1ecfa…9c80585c8c6e…

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
A077526-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-26
A077526-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077526-001AB
A077526-002AB

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 UTC2026-02A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077526-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2013-03-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A077526-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2013-03-26782e0a99824c…

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 UTC2026-02A077526-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077526-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077526-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077526-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077526-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077526-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077526-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077526-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077526-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077526-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077526-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077526-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077526-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077526-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077526-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077526-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077526-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077526-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077526-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077526-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077526-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077526-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077526-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077526-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077526-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077526-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077526-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077526-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077526-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077526-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077526-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077526-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077526-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077526-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077526-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077526-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077526-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077526-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077526-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077526-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-181-65EA - Each69097-1811e207f4d-4a09-4e6d-881b-3e467959561d12015-10-02
69097-181-66EA - Each69097-1815d4a0b33-4de9-449b-87ea-9813b05e551c12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.]1
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.]1