relpax

Generic: eletriptan hydrobromide

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name relpax
Generic Name eletriptan hydrobromide
Labeler viatris specialty llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

eletriptan hydrobromide 40 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-368
Product ID 58151-368_ca50a848-b287-47b6-980b-5729d4582893
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021016
Listing Expiration 2026-12-31
Marketing Start 2024-08-21

Pharmacologic Class

Classes
serotonin 1b receptor agonists [moa] serotonin 1d receptor agonists [moa] serotonin-1b and serotonin-1d receptor agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58151368
Hyphenated Format 58151-368

Supplemental Identifiers

RxCUI
359493 359494 404443 404444
UNII
M41W832TA3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name relpax (source: ndc)
Generic Name eletriptan hydrobromide (source: ndc)
Application Number NDA021016 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (58151-368-56) / 1 TABLET in 1 BLISTER PACK
  • 12 BLISTER PACK in 1 CARTON (58151-368-96) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

58151-368-56 6 BLISTER PACK in 1 CARTON (58151-368-56) / 1 TABLET in 1 BLISTER PACK 58151-368-96 12 BLISTER PACK in 1 CARTON (58151-368-96) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

eletriptan hydrobromide (40 mg/1)

Linked Drug Pages (1)

Relpax ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ca50a848-b287-47b6-980b-5729d4582893", "openfda": {"unii": ["M41W832TA3"], "rxcui": ["359493", "359494", "404443", "404444"], "spl_set_id": ["2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (58151-368-56)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "58151-368-56", "marketing_start_date": "20240821"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (58151-368-96)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "58151-368-96", "marketing_start_date": "20250123"}], "brand_name": "Relpax", "product_id": "58151-368_ca50a848-b287-47b6-980b-5729d4582893", "dosage_form": "TABLET", "pharm_class": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "58151-368", "generic_name": "eletriptan hydrobromide", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Relpax", "active_ingredients": [{"name": "ELETRIPTAN HYDROBROMIDE", "strength": "40 mg/1"}], "application_number": "NDA021016", "marketing_category": "NDA", "marketing_start_date": "20240821", "listing_expiration_date": "20261231"}