eletriptan hydrobromide

Generic: eletriptan hydrobromide

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

Drug Facts

Product Profile

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

eletriptan hydrobromide 20 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-922
Product ID 68382-922_669aad4d-c160-4be8-bca9-bdbaf0f3c8a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206409
Listing Expiration 2026-12-31
Marketing Start 2017-07-12

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 68382922
Hyphenated Format 68382-922

Supplemental Identifiers

RxCUI
359493 359494
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 ANDA206409 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68382-922-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-922-10)
  • 10 BLISTER PACK in 1 CARTON (68382-922-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-922-30)
  • 1 BLISTER PACK in 1 CARTON (68382-922-86) / 6 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

68382-922-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-922-06) 68382-922-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-922-10) 68382-922-77 10 BLISTER PACK in 1 CARTON (68382-922-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-922-30) 68382-922-86 1 BLISTER PACK in 1 CARTON (68382-922-86) / 6 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

eletriptan hydrobromide (20 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": "669aad4d-c160-4be8-bca9-bdbaf0f3c8a3", "openfda": {"unii": ["M41W832TA3"], "rxcui": ["359493", "359494"], "spl_set_id": ["e0dfeb1f-f0f0-449a-81ae-2c8fdddcff10"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-922-06)", "package_ndc": "68382-922-06", "marketing_start_date": "20170712"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-922-10)", "package_ndc": "68382-922-10", "marketing_start_date": "20170712"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-922-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-922-30)", "package_ndc": "68382-922-77", "marketing_start_date": "20170712"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68382-922-86)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68382-922-86", "marketing_start_date": "20170712"}], "brand_name": "Eletriptan hydrobromide", "product_id": "68382-922_669aad4d-c160-4be8-bca9-bdbaf0f3c8a3", "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": "68382-922", "generic_name": "Eletriptan hydrobromide", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eletriptan hydrobromide", "active_ingredients": [{"name": "ELETRIPTAN HYDROBROMIDE", "strength": "20 mg/1"}], "application_number": "ANDA206409", "marketing_category": "ANDA", "marketing_start_date": "20170712", "listing_expiration_date": "20261231"}