Home NDC 80425-0408 Eletriptan Hydrobromide
Product NDC 80425-0408
11-digit product format 804250408
Labeler code 80425
Product ID 80425-0408_1bbcb1f8-d717-a171-e063-6394a90a5d98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eletriptan Hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA210708
Marketing category ANDA
Marketing start 2024-06-25
Substance ELETRIPTAN HYDROBROMIDE
Active strength 40 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 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 A210708-001 ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 A210708-002 ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15
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 · 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 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210708-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2019-01-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210708-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2019-01-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Eletriptan Hydrobromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELETRIPTAN HYDROBROMIDE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M41W832TA3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 359494 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 80425-0408-1 Eletriptan Hydrobromide 6 in 1 BLISTER PACK TABLET, FILM COATED 6 1 80425-0408-1 Eletriptan Hydrobromide 1 in 1 CARTON TABLET, FILM COATED 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0408 ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] 1 Current NDC, 2 package rows 20240627_1bbcb13f-d1cb-82c1-e063-6394a90a7753.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 80425-0408-1 80425040801 1 BLISTER PACK in 1 CARTON (80425-0408-1) / 6 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2024-06-25 No No Current