eletriptan hydrobromide

Generic: eletriptan hydrobromide

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eletriptan hydrobromide
Generic Name eletriptan hydrobromide
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eletriptan hydrobromide 40 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4288
Product ID 0378-4288_cba8e2c4-eb4b-49c7-83be-d5cfb58b23d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205152
Listing Expiration 2026-12-31
Marketing Start 2017-08-15

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 03784288
Hyphenated Format 0378-4288

Supplemental Identifiers

RxCUI
359493 359494
UPC
0303784287859
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 eletriptan hydrobromide (source: ndc)
Generic Name eletriptan hydrobromide (source: ndc)
Application Number ANDA205152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0378-4288-08) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32)
  • 1 BLISTER PACK in 1 CARTON (0378-4288-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32)
source: ndc

Packages (2)

0378-4288-08 2 BLISTER PACK in 1 CARTON (0378-4288-08) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32) 0378-4288-85 1 BLISTER PACK in 1 CARTON (0378-4288-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32)

Ingredients (1)

eletriptan hydrobromide (40 mg/1)

Linked Drug Pages (1)

Eletriptan Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cba8e2c4-eb4b-49c7-83be-d5cfb58b23d9", "openfda": {"upc": ["0303784287859"], "unii": ["M41W832TA3"], "rxcui": ["359493", "359494"], "spl_set_id": ["20276f5c-f2d6-469f-9a1b-aa254a1db21c"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0378-4288-08)  / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32)", "package_ndc": "0378-4288-08", "marketing_start_date": "20170816"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0378-4288-85)  / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32)", "package_ndc": "0378-4288-85", "marketing_start_date": "20170815"}], "brand_name": "Eletriptan Hydrobromide", "product_id": "0378-4288_cba8e2c4-eb4b-49c7-83be-d5cfb58b23d9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "0378-4288", "generic_name": "eletriptan hydrobromide", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eletriptan Hydrobromide", "active_ingredients": [{"name": "ELETRIPTAN HYDROBROMIDE", "strength": "40 mg/1"}], "application_number": "ANDA205152", "marketing_category": "ANDA", "marketing_start_date": "20170815", "listing_expiration_date": "20261231"}