Home NDC 58151-368 Relpax
Product NDC 58151-368
11-digit product format 581510368
Labeler code 58151
Product ID 58151-368_ca50a848-b287-47b6-980b-5729d4582893
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eletriptan hydrobromide
Dosage form TABLET
Route ORAL
Labeler Viatris Specialty LLC
Application NDA021016
Marketing category NDA
Marketing start 2024-08-21
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 N021016-001 RELPAX ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 N021016-002 RELPAX ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26
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 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021016-001 RELPAX EQ 20MG BASE TABLET / ORAL AB RLD 2002-12-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021016-002 RELPAX EQ 40MG BASE TABLET / ORAL AB RLD, RS 2002-12-26 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 Relpax
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 359493 Internal RxNorm lookup 359494 Internal RxNorm lookup 404443 Internal RxNorm lookup 404444 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 58151-368-56 Relpax 1 in 1 BLISTER PACK TABLET 1 4 58151-368-56 Relpax 6 in 1 CARTON TABLET 6 4 58151-368-96 Relpax 12 in 1 CARTON TABLET 12 4 58151-368-96 Relpax 1 in 1 BLISTER PACK TABLET 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-368 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET [VIATRIS SPECIALTY LLC] 4 Current NDC, 4 package rows 20250510_2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Relpax ELETRIPTAN HYDROBROMIDE Viatris Specialty LLC 2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e 2024-01-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 021016 application number: NDA021016 ndc (product): 58151-368
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58151-368-56 58151036856 6 BLISTER PACK in 1 CARTON (58151-368-56) / 1 TABLET in 1 BLISTER PACK 6 blister pack 2024-08-21 No No Current 58151-368-96 58151036896 12 BLISTER PACK in 1 CARTON (58151-368-96) / 1 TABLET in 1 BLISTER PACK 12 blister pack 2025-01-23 No No Current