Home NDC 63629-8320-2 Eletriptan Hydrobromide
Product NDC 63629-8320
Requested package NDC 63629-8320-2
11-digit product format 636298320
Labeler code 63629
Product ID 63629-8320_ac134921-c0d8-46a0-96a7-014ff1e4aa95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eletriptan Hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA210708
Marketing category ANDA
Marketing start 2018-02-16
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63629-8320 63629-8320-2 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 63629-8320-1 Eletriptan Hydrobromide 9 in 1 BOTTLE TABLET, FILM COATED 9 1003 63629-8320-2 Eletriptan Hydrobromide 30 in 1 BOTTLE TABLET, FILM COATED 30 1003
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8320 ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1003 Current NDC, Legacy NDC, 2 package rows 20240915_a3953ca6-3da6-4420-9eb5-a16b38372f4e.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 Marketing start Marketing end Sample Exclude flag Status 63629-8320-2 63629832002 30 TABLET, FILM COATED in 1 BOTTLE (63629-8320-2) 2021-12-07 0000-00-00 No No Current