Home NDC 0049-2340-05 Relpax
Product NDC 0049-2340
Requested package NDC 0049-2340-05
11-digit product format 000492340
Labeler code 0049
Product ID 0049-2340_60fa2e8b-4d0d-4546-a087-3f0efb3e7560
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eletriptan hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Roerig
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 2022-12-31
Current FDA listing Historical FDA.report record 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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0049-2340-05 Relpax 12 in 1 CARTON TABLET, FILM COATED 12 25 0049-2340-45 Relpax 6 in 1 CARTON TABLET, FILM COATED 6 25 0049-2340-79 Relpax 1 in 1 BLISTER PACK TABLET, FILM COATED 1 25
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 [ROERIG] 13 ELETRIPTAN ACTIVE MOIETY 22QOO9B8KI RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 LACTOSE INACTIVE INGREDIENT J2B2A4N98G RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 13 eletriptan hydrobromide ACTIVE INGREDIENT M41W832TA3 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 eletriptan hydrobromide ACTIVE INGREDIENT M41W832TA3 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 eletriptan hydrobromide ACTIVE INGREDIENT M41W832TA3 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 eletriptan ACTIVE MOIETY 22QOO9B8KI RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 eletriptan ACTIVE MOIETY 22QOO9B8KI RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 eletriptan ACTIVE MOIETY 22QOO9B8KI RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 lactose INACTIVE INGREDIENT J2B2A4N98G RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 lactose INACTIVE INGREDIENT J2B2A4N98G RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 lactose INACTIVE INGREDIENT J2B2A4N98G RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 triacetin INACTIVE INGREDIENT XHX3C3X673 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 triacetin INACTIVE INGREDIENT XHX3C3X673 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 triacetin INACTIVE INGREDIENT XHX3C3X673 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [STAT RX USA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0049-2340 RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET, FILM COATED [ROERIG] 24 Legacy NDC, 3 package rows 20250510_85745375-fcb6-4edc-b6db-a77b4a5f3e8c.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
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 0049-2340-05 00049234005 12 BLISTER PACK in 1 CARTON (0049-2340-05) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0049-2340-79) 12 blister pack 2002-12-26 0000-00-00 No No Current