NDC 0378-4288

Eletriptan Hydrobromide

Eletriptan Hydrobromide

Eletriptan Hydrobromide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Eletriptan Hydrobromide.

Product ID0378-4288_9e633cc0-d484-40b0-b841-a0be6f1192b1
NDC0378-4288
Product TypeHuman Prescription Drug
Proprietary NameEletriptan Hydrobromide
Generic NameEletriptan Hydrobromide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-08-15
Marketing CategoryANDA / ANDA
Application NumberANDA205152
Labeler NameMylan Pharmaceuticals Inc.
Substance NameELETRIPTAN HYDROBROMIDE
Active Ingredient Strength40 mg/1
Pharm ClassesSerotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-4288-08

2 BLISTER PACK in 1 CARTON (0378-4288-08) > 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32)
Marketing Start Date2017-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4288-32 [00378428832]

Eletriptan Hydrobromide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-15

NDC 0378-4288-08 [00378428808]

Eletriptan Hydrobromide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-16

NDC 0378-4288-85 [00378428885]

Eletriptan Hydrobromide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-15

Drug Details

Active Ingredients

IngredientStrength
ELETRIPTAN HYDROBROMIDE40 mg/1

OpenFDA Data

SPL SET ID:20276f5c-f2d6-469f-9a1b-aa254a1db21c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359494
  • 359493
    • UPC Code
  • 0303784287859

    • Pharmacological Class

    • Serotonin 1b Receptor Agonists [MoA]
    • Serotonin 1d Receptor Agonists [MoA]
    • Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
    • Serotonin 1b Receptor Agonists [MoA]
    • Serotonin 1d Receptor Agonists [MoA]
    • Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]

    NDC Crossover Matching brand name "Eletriptan Hydrobromide" or generic name "Eletriptan Hydrobromide"

    NDCBrand NameGeneric Name
    0093-8310Eletriptan HydrobromideEletriptan Hydrobromide
    0093-8311Eletriptan HydrobromideEletriptan Hydrobromide
    0378-4287Eletriptan Hydrobromideeletriptan hydrobromide
    0378-4288Eletriptan Hydrobromideeletriptan hydrobromide
    27241-039eletriptan hydrobromideeletriptan hydrobromide
    27241-040eletriptan hydrobromideeletriptan hydrobromide
    55700-756eletriptan hydrobromideeletriptan hydrobromide
    59651-104Eletriptan HydrobromideEletriptan Hydrobromide
    59651-105Eletriptan HydrobromideEletriptan Hydrobromide
    68382-923Eletriptan hydrobromideEletriptan hydrobromide
    68382-922Eletriptan hydrobromideEletriptan hydrobromide
    70771-1107Eletriptan hydrobromideEletriptan hydrobromide
    70771-1108Eletriptan hydrobromideEletriptan hydrobromide
    65162-042Eletriptan HydrobromideEletriptan Hydrobromide
    65162-043Eletriptan HydrobromideEletriptan Hydrobromide
    63629-8320Eletriptan HydrobromideEletriptan Hydrobromide
    0049-2330Relpaxeletriptan hydrobromide
    0049-2340Relpaxeletriptan hydrobromide
    21695-871Relpaxeletriptan hydrobromide
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