FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Relpax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELETRIPTAN HYDROBROMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM41W832TA3
Rxcui359493, 359494, 404443, 404444

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca727413-0b46-77de-6659-26418dfe7a5aProduct name620230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-368-56Relpax1 in 1 BLISTER PACKTABLET14
58151-368-56Relpax6 in 1 CARTONTABLET64
58151-368-96Relpax12 in 1 CARTONTABLET124
58151-368-96Relpax1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-368-56EA - Each58151-368d5e7649d-ab6d-4794-ac6b-6b5957e71c5912024-09-09
58151-368-96EA - Each58151-368270b18f4-d048-45c0-9f0e-e91b094e1b4d12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-368RELPAX (ELETRIPTAN HYDROBROMIDE) TABLET [VIATRIS SPECIALTY LLC]4Current NDC, 4 package rows20250510_2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSN2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
359494eletriptan HBr 40 MG Oral TabletPSN2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
404443RELPAX 20 MG Oral TabletPSN2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
404444RELPAX 40 MG Oral TabletPSN2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
404443eletriptan 20 MG Oral Tablet [Relpax]SBD2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
404444eletriptan 40 MG Oral Tablet [Relpax]SBD2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
359493eletriptan 20 MG Oral TabletSCD2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
359494eletriptan 40 MG Oral TabletSCD2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSY2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
404444Relpax (as eletriptan hydrobromide) 40 MG Oral TabletSY2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4
404443Relpax 20 MG Oral TabletSY2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58151-368-56581510368566 BLISTER PACK in 1 CARTON (58151-368-56) / 1 TABLET in 1 BLISTER PACK6 blister pack2024-08-21NoNoCurrent
58151-368-965815103689612 BLISTER PACK in 1 CARTON (58151-368-96) / 1 TABLET in 1 BLISTER PACK12 blister pack2025-01-23NoNoCurrent