NDC 0054-0521

Bosentan

Bosentan

Bosentan is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Bosentan.

Product ID0054-0521_03c560f4-2afd-4b15-9466-cff8a3627610
NDC0054-0521
Product TypeHuman Prescription Drug
Proprietary NameBosentan
Generic NameBosentan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-06-04
Marketing CategoryANDA / ANDA
Application NumberANDA208695
Labeler NameWest-Ward Pharmaceuticals Corp.
Substance NameBOSENTAN
Active Ingredient Strength125 mg/1
Pharm ClassesEndothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0054-0521-21

60 TABLET in 1 BOTTLE (0054-0521-21)
Marketing Start Date2019-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0521-21 [00054052121]

Bosentan TABLET
Marketing CategoryANDA
Application NumberANDA208695
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-04

Drug Details

Active Ingredients

IngredientStrength
BOSENTAN125 mg/1

Pharmacological Class

  • Endothelin Receptor Antagonist [EPC]
  • Endothelin Receptor Antagonists [MoA]
  • Cytochrome P450 3A Inducers [MoA]
  • Cytochrome P450 2C9 Inducers [MoA]

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

NDCBrand NameGeneric Name
0054-0520BosentanBosentan
0054-0521BosentanBosentan
0591-2511bosentanbosentan
0591-2512bosentanbosentan
10148-125bosentanbosentan
10148-625bosentanbosentan
46708-383BosentanBosentan
46708-384BosentanBosentan
47335-038BosentanBosentan
47335-039BosentanBosentan
47781-270BosentanBosentan
47781-271BosentanBosentan
49884-058BosentanBosentan
49884-059BosentanBosentan
62332-383BosentanBosentan
62332-384BosentanBosentan
65162-873BosentanBosentan
65162-874BosentanBosentan
69097-377BOSENTANBOSENTAN
69097-378BOSENTANBOSENTAN
68382-446BosentanBosentan
68382-447BosentanBosentan
70771-1017BosentanBosentan
70771-1018BosentanBosentan
68180-387BosentanBosentan
68180-386BosentanBosentan
66215-101Tracleerbosentan

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