NDC 0378-5245

Almotriptan Malate

Almotriptan

Almotriptan Malate 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 Almotriptan Malate.

Product ID0378-5245_24da4379-1283-4c66-97bd-643b27a15368
NDC0378-5245
Product TypeHuman Prescription Drug
Proprietary NameAlmotriptan Malate
Generic NameAlmotriptan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-11-10
Marketing CategoryANDA / ANDA
Application NumberANDA205171
Labeler NameMylan Pharmaceuticals Inc.
Substance NameALMOTRIPTAN MALATE
Active Ingredient Strength6 mg/1
Pharm ClassesSerotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-5245-85

1 BLISTER PACK in 1 CARTON (0378-5245-85) > 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-5245-32)
Marketing Start Date2015-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5245-32 [00378524532]

Almotriptan Malate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-10

NDC 0378-5245-93 [00378524593]

Almotriptan Malate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-10
Marketing End Date2017-07-20

NDC 0378-5245-01 [00378524501]

Almotriptan Malate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-10
Marketing End Date2017-07-20

NDC 0378-5245-85 [00378524585]

Almotriptan Malate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-10

NDC 0378-5245-56 [00378524556]

Almotriptan Malate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-10
Marketing End Date2017-07-20

Drug Details

Active Ingredients

IngredientStrength
ALMOTRIPTAN MALATE6.25 mg/1

OpenFDA Data

SPL SET ID:35617039-9f33-401b-bac3-8f85c65fa2c7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 284204
  • 284205
  • UPC Code
  • 0303785246855
  • 0303785245858
  • Pharmacological Class

    • 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]
    • Serotonin 1b Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Almotriptan Malate" or generic name "Almotriptan"

    NDCBrand NameGeneric Name
    0093-5260Almotriptan MalateAlmotriptan Malate
    0093-5261Almotriptan MalateAlmotriptan Malate
    0378-5245Almotriptan MalateAlmotriptan
    0378-5246Almotriptan MalateAlmotriptan
    27241-041almotriptanalmotriptan
    27241-042almotriptanalmotriptan
    50458-210AXERTalmotriptan malate
    50458-211AXERTalmotriptan malate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.