Home NDC 68382-923 Eletriptan hydrobromide
Product NDC 68382-923
11-digit product format 683820923
Labeler code 68382
Product ID 68382-923_669aad4d-c160-4be8-bca9-bdbaf0f3c8a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eletriptan hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA206409
Marketing category ANDA
Marketing start 2017-07-12
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 A206409-001 ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 A206409-002 ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16
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 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206409-001 ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2017-06-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206409-002 ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2017-06-16 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 359493 Internal RxNorm lookup 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 68382-923-05 Eletriptan hydrobromide 500 in 1 BOTTLE TABLET, FILM COATED 500 5 68382-923-06 Eletriptan hydrobromide 30 in 1 BOTTLE TABLET, FILM COATED 30 5 68382-923-30 Eletriptan hydrobromide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 5 68382-923-77 Eletriptan hydrobromide 10 in 1 CARTON TABLET, FILM COATED 10 5 68382-923-86 Eletriptan hydrobromide 1 in 1 CARTON TABLET, FILM COATED 1 5 68382-923-86 Eletriptan hydrobromide 6 in 1 BLISTER PACK TABLET, FILM COATED 6 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-923 ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 6 package rows 20230921_e0dfeb1f-f0f0-449a-81ae-2c8fdddcff10.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 · 3 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 68382-923-05 68382092305 500 TABLET, FILM COATED in 1 BOTTLE (68382-923-05) 2017-07-12 0000-00-00 No No Current 68382-923-06 68382092306 30 TABLET, FILM COATED in 1 BOTTLE (68382-923-06) 2017-07-12 0000-00-00 No No Current 68382-923-30 68382092330 10 in 1 BLISTER PACK Historical 68382-923-77 68382092377 10 BLISTER PACK in 1 CARTON (68382-923-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-923-30) 10 blister pack 2017-07-12 0000-00-00 No No Current 68382-923-86 68382092386 1 BLISTER PACK in 1 CARTON (68382-923-86) / 6 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2017-07-12 0000-00-00 No No Current