Home NDC 70771-1107 Eletriptan hydrobromide
Product NDC 70771-1107
11-digit product format 707711107
Labeler code 70771
Product ID 70771-1107_b0459347-b3de-466e-b386-85665dd294c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eletriptan hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA206409
Marketing category ANDA
Marketing start 2017-07-12
Substance ELETRIPTAN HYDROBROMIDE
Active strength 20 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 20 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 70771-1107-0 Eletriptan hydrobromide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7 70771-1107-2 Eletriptan hydrobromide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 7 70771-1107-3 Eletriptan hydrobromide 30 in 1 BOTTLE TABLET, FILM COATED 30 7 70771-1107-4 Eletriptan hydrobromide 10 in 1 CARTON TABLET, FILM COATED 10 7 70771-1107-6 Eletriptan hydrobromide 1 in 1 CARTON TABLET, FILM COATED 1 7 70771-1107-6 Eletriptan hydrobromide 6 in 1 BLISTER PACK TABLET, FILM COATED 6 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1107 ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 7 Current NDC, Legacy NDC, 6 package rows 20241201_481ae7d4-9e57-424a-9d07-2920954b6ddc.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 70771-1107-0 70771110700 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1107-0) 2017-07-12 0000-00-00 No No Current 70771-1107-2 70771110702 10 in 1 BLISTER PACK Historical 70771-1107-3 70771110703 30 TABLET, FILM COATED in 1 BOTTLE (70771-1107-3) 2017-07-12 0000-00-00 No No Current 70771-1107-4 70771110704 10 BLISTER PACK in 1 CARTON (70771-1107-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1107-2) 10 blister pack 2017-07-12 0000-00-00 No No Current 70771-1107-6 70771110706 1 BLISTER PACK in 1 CARTON (70771-1107-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2017-07-12 0000-00-00 No No Current