Home NDC 69097-865-85 Rizatriptan Benzoate
Product NDC 69097-865
Requested package NDC 69097-865-85
11-digit product format 690970865
Labeler code 69097
Product ID 69097-865_6ace7fac-e700-4a32-95ce-07ffbd0201ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rizatriptan Benzoate
Dosage form TABLET
Route ORAL
Labeler Cipla USA Inc.
Application ANDA204339
Marketing category ANDA
Marketing start 2016-07-22
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204339-001 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 A204339-002 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL 2013-07-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL 2013-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-07-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-07-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-07-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-07-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-07-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204339-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-07-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204339-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-07-01 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Rizatriptan Benzoate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIZATRIPTAN BENZOATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WR978S7QHH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312840 Internal RxNorm lookup 314209 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69097-865-17 Rizatriptan Benzoate 6 in 1 BLISTER PACK TABLET 6 6 69097-865-85 Rizatriptan Benzoate 3 in 1 CARTON TABLET 3 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-865 RIZATRIPTAN BENZOATE TABLET [CIPLA USA INC.] 6 Current NDC, Legacy NDC, 2 package rows 20220114_f462a507-921c-41c2-93ba-36003b6e8914.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69097-865-85 69097086585 3 TABLET in 1 CARTON (69097-865-85) 3 tablet 2016-07-22 0000-00-00 No No Current