Home NDC 63539-234-79 Relpax
Product NDC 63539-234
Requested package NDC 63539-234-79
11-digit product format 635390234
Labeler code 63539
Product ID 63539-234_a35d1272-c5b6-4481-a447-d46fc12a8b11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eletriptan hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler U.S. Pharmaceuticals
Application NDA021016
Marketing category NDA
Marketing start 2002-12-26
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ELETRIPTAN HYDROBROMIDE ACTIVE INGREDIENT M41W832TA3 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 ELETRIPTAN ACTIVE MOIETY 22QOO9B8KI RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 2
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63539-234-79 63539023479 1 TABLET, FILM COATED in 1 BLISTER PACK (63539-234-79) 2002-12-26 0000-00-00 No No Current