NDC 49884-354

Ambrisentan

Ambrisentan

Ambrisentan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Ambrisentan.

Product ID49884-354_3d907352-b0a8-4d87-bb3f-235433818d10
NDC49884-354
Product TypeHuman Prescription Drug
Proprietary NameAmbrisentan
Generic NameAmbrisentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-16
Marketing End Date2022-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA209509
Labeler NamePar Pharmaceutical, Inc.
Substance NameAMBRISENTAN
Active Ingredient Strength10 mg/1
Pharm ClassesEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC Exclude FlagN

Packaging

NDC 49884-354-11

30 TABLET, FILM COATED in 1 BOTTLE (49884-354-11)
Marketing Start Date2019-04-16
Marketing End Date2022-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-354-62 [49884035462]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209509
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-16

NDC 49884-354-11 [49884035411]

Ambrisentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209509
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-16

Drug Details

Active Ingredients

IngredientStrength
AMBRISENTAN10 mg/1

OpenFDA Data

SPL SET ID:3b9ec5f8-6e77-4fd8-93fe-7055079323af
Manufacturer
UNII
UPC Code
  • 0349884354114
  • 0349884353117
  • 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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