Home NDC 72189-434 Zolmitriptan
Product NDC 72189-434
11-digit product format 721890434
Labeler code 72189
Product ID 72189-434_2c4d7dfd-fbd3-516b-e063-6394a90add1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolmitriptan
Dosage form TABLET
Route ORAL
Labeler Direct_Rx
Application ANDA204041
Marketing category ANDA
Marketing start 2023-03-13
Substance ZOLMITRIPTAN
Active strength 2.5 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 72189-434-06 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 72189-434-06 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 A204041-001 ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 A204041-002 ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20
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 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB RS 2016-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204041-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204041-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-20 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 Zolmitriptan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLMITRIPTAN 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2FS66TH3YW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200193 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 72189-434-06 Zolmitriptan 6 in 1 BOTTLE TABLET 6 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-434 ZOLMITRIPTAN TABLET [DIRECT_RX] 4 Current NDC, 1 package rows 20250123_f6ca7d28-8322-f151-e053-6394a90a39b7.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72189-434-06 72189043406 6 TABLET in 1 BOTTLE (72189-434-06) 6 tablet 2023-03-13 No No Current