Home NDC 72189-316 RIZATRIPTAN BENZOATE
Product NDC 72189-316
11-digit product format 721890316
Labeler code 72189
Product ID 72189-316_2c3d1d1c-309d-23dd-e063-6294a90ac2ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RIZATRIPTAN BENZOATE
Dosage form TABLET
Route ORAL
Labeler Direct Rx
Application ANDA203269
Marketing category ANDA
Marketing start 2022-01-20
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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-316-18 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-316-18 0efc9e666f02…f202fb6c5f17…
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 A203269-001 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 A203269-002 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203269-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2016-02-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203269-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2016-02-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312840 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 72189-316-18 RIZATRIPTAN BENZOATE 18 in 1 BOTTLE TABLET 18 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-316 RIZATRIPTAN BENZOATE TABLET [DIRECT RX] 2 Current NDC, Legacy NDC, 1 package rows 20250122_d60560d5-8e52-099d-e053-2a95a90a20af.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.
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 72189-316-18 72189031618 18 TABLET in 1 BOTTLE (72189-316-18) 18 tablet 2022-01-20 0000-00-00 No No Current