MAXALT-MLT

Product NDC
78206-143
11-digit product format
782060143
Labeler code
78206
Product ID
78206-143_47257235-a46d-4fee-a29d-08f8ba8e46c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Organon LLC
Application
NDA020865
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 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
N020865-001MAXALT-MLTRIZATRIPTAN BENZOATEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-29
N020865-002MAXALT-MLTRIZATRIPTAN BENZOATEEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020865-002AB

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 UTC2026-02N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020865-001MAXALT-MLTEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020865-001MAXALT-MLTEQ 5MG BASETABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020865-001MAXALT-MLTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD1998-06-29782e0a99824c…
2021-12-28 21:50 UTC2021-12N020865-002MAXALT-MLTEQ 10MG BASETABLET, ORALLY DISINTEGRATING / ORALABRLD, RS1998-06-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020865-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020865-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020865-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020865-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020865-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020865-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020865-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020865-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020865-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020865-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020865-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020865-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020865-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020865-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020865-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020865-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020865-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020865-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020865-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020865-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020865-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020865-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020865-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020865-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020865-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020865-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020865-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020865-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020865-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020865-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020865-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020865-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020865-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020865-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020865-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020865-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020865-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020865-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020865-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020865-002AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
MAXALT-MLT
Listing expiration
2027-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213322Internal RxNorm lookup
312837Internal RxNorm lookup
314209Internal RxNorm lookup
828537Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
007b4644-e0e7-4863-9ae3-fe09676b3f5fAvailable 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b537454-32b8-7e64-1395-258682782d07Product name520170424
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-143-01MAXALT-MLT6 in 1 CARTONTABLET, ORALLY DISINTEGRATING64
78206-143-01MAXALT-MLT3 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING34
78206-143-99MAXALT-MLT1 in 1 POUCHTABLET, ORALLY DISINTEGRATING14
78206-143-99MAXALT-MLT1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-143-01EA - Each78206-14377ab0153-3bdb-4346-9dc5-33fbbd90b0f812021-10-08
78206-143-99EA - Each78206-143714282c9-94e7-42b7-924a-b0cda016da5a12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-143MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [ORGANON LLC]2Current NDC, Legacy NDC, 4 package rows20220623_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXALTRIZATRIPTAN BENZOATEOrganon LLC007b4644-e0e7-4863-9ae3-fe09676b3f5f2026-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 020865
application number: NDA020865
ndc (product): 78206-143

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213322Maxalt 10 MG Oral TabletPSN007b4644-e0e7-4863-9ae3-fe09676b3f5f4
828537Maxalt-MLT 10 MG Disintegrating Oral TabletPSN007b4644-e0e7-4863-9ae3-fe09676b3f5f4
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN007b4644-e0e7-4863-9ae3-fe09676b3f5f4
314209rizatriptan benzoate 10 MG Oral TabletPSN007b4644-e0e7-4863-9ae3-fe09676b3f5f4
828537rizatriptan 10 MG Disintegrating Oral Tablet [Maxalt]SBD007b4644-e0e7-4863-9ae3-fe09676b3f5f4
213322rizatriptan 10 MG Oral Tablet [Maxalt]SBD007b4644-e0e7-4863-9ae3-fe09676b3f5f4
312837rizatriptan 10 MG Disintegrating Oral TabletSCD007b4644-e0e7-4863-9ae3-fe09676b3f5f4
314209rizatriptan 10 MG Oral TabletSCD007b4644-e0e7-4863-9ae3-fe09676b3f5f4
828537Maxalt 10 MG Disintegrating Oral TabletSY007b4644-e0e7-4863-9ae3-fe09676b3f5f4
213322Maxalt 10 MG Oral TabletSY007b4644-e0e7-4863-9ae3-fe09676b3f5f4
828537Maxalt-MLT 10 MG Disintegrating Oral TabletSY007b4644-e0e7-4863-9ae3-fe09676b3f5f4
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY007b4644-e0e7-4863-9ae3-fe09676b3f5f4
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY007b4644-e0e7-4863-9ae3-fe09676b3f5f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-143-01782060143016 CONTAINER in 1 CARTON (78206-143-01) / 3 POUCH in 1 CONTAINER / 1 BLISTER PACK in 1 POUCH (78206-143-99) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 container2021-06-010000-00-00NoNoCurrent
78206-143-99782060143991 in 1 POUCHHistorical