Home NDC 78206-142 MAXALT
Product NDC 78206-142
11-digit product format 782060142
Labeler code 78206
Product ID 78206-142_47257235-a46d-4fee-a29d-08f8ba8e46c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rizatriptan benzoate
Dosage form TABLET
Route ORAL
Labeler Organon LLC
Application NDA020864
Marketing category NDA
Marketing start 2021-06-01
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020864-001 MAXALT RIZATRIPTAN BENZOATE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 N020864-002 MAXALT RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020864-002 AB
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 · 84 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 2026-08-18 06:07:40 2026-07 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020864-001 MAXALT EQ 5MG BASE TABLET / ORAL RLD 1998-06-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020864-001 MAXALT EQ 5MG BASE TABLET / ORAL RLD 1998-06-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1998-06-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020864-001 MAXALT EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-06-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020864-002 MAXALT EQ 10MG BASE TABLET / ORAL AB RLD, RS 1998-06-29 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MAXALT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIZATRIPTAN BENZOATE 10 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213322 Internal RxNorm lookup 312837 Internal RxNorm lookup 314209 Internal RxNorm lookup 828537 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 78206-142-01 MAXALT 18 in 1 CARTON TABLET 18 4 78206-142-99 MAXALT 1 in 1 POUCH TABLET 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-142 MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [ORGANON LLC] 2 Current NDC, Legacy NDC, 2 package rows 20220623_007b4644-e0e7-4863-9ae3-fe09676b3f5f.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.
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 78206-142-01 78206014201 18 POUCH in 1 CARTON (78206-142-01) / 1 TABLET in 1 POUCH (78206-142-99) 18 pouch 2021-06-01 0000-00-00 No No Current 78206-142-99 78206014299 1 in 1 POUCH Historical