NDC 0378-4270

Ambrisentan

Ambrisentan

Ambrisentan 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 Ambrisentan.

Product ID0378-4270_3ea35030-c5e4-4f6a-a83a-9fb41e436a9d
NDC0378-4270
Product TypeHuman Prescription Drug
Proprietary NameAmbrisentan
Generic NameAmbrisentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA208441
Labeler NameMylan Pharmaceuticals Inc.
Substance NameAMBRISENTAN
Active Ingredient Strength5 mg/1
Pharm ClassesEndothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-4270-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4270-93)
Marketing Start Date2019-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4270-32 [00378427032]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208441
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-29
Marketing End Date2019-10-03

NDC 0378-4270-93 [00378427093]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208441
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-29

Drug Details

Active Ingredients

IngredientStrength
AMBRISENTAN5 mg/1

OpenFDA Data

SPL SET ID:8080b009-361b-4505-b09a-0d91a0e4a2c0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 722122
  • 722116
  • UPC Code
  • 0303784271971
  • 0303784270974
  • Pharmacological Class

    • Endothelin Receptor Antagonist [EPC]
    • Endothelin Receptor Antagonists [MoA]

    NDC Crossover Matching brand name "Ambrisentan" or generic name "Ambrisentan"

    NDCBrand NameGeneric Name
    0378-4270Ambrisentanambrisentan
    0378-4271Ambrisentanambrisentan
    0591-2405AmbrisentanAmbrisentan
    0591-2406AmbrisentanAmbrisentan
    42291-018AMBRISENTANAMBRISENTAN
    42291-019AMBRISENTANAMBRISENTAN
    42794-051AMBRISENTANAMBRISENTAN
    42794-052AMBRISENTANAMBRISENTAN
    47335-236ambrisentanambrisentan
    47335-237ambrisentanambrisentan
    49884-353AmbrisentanAmbrisentan
    49884-354AmbrisentanAmbrisentan
    59651-494ambrisentanambrisentan
    59651-495ambrisentanambrisentan
    60505-4552AmbrisentanAMBRISENTAN
    60505-4553AmbrisentanAMBRISENTAN
    69097-386AmbrisentanAmbrisentan
    69097-387AmbrisentanAmbrisentan
    70710-1179AmbrisentanAmbrisentan
    70710-1180AmbrisentanAmbrisentan
    70771-1363AmbrisentanAmbrisentan
    70771-1364AmbrisentanAmbrisentan
    76282-684AmbrisentanAmbrisentan
    76282-685AmbrisentanAmbrisentan
    61958-0801LetairisAMBRISENTAN
    61958-0802LetairisAMBRISENTAN

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