NDC 46708-384

Bosentan

Bosentan

Bosentan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Bosentan.

Product ID46708-384_e67f1476-1394-4c2c-b03e-a80d0d4da5cb
NDC46708-384
Product TypeHuman Prescription Drug
Proprietary NameBosentan
Generic NameBosentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-01-24
Marketing CategoryANDA / ANDA
Application NumberANDA211461
Labeler NameAlembic Pharmaceuticals Limited
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 Through2021-12-31

Packaging

NDC 46708-384-10

100 TABLET, FILM COATED in 1 CARTON (46708-384-10)
Marketing Start Date2020-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-384-60 [46708038460]

Bosentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211461
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-24

NDC 46708-384-10 [46708038410]

Bosentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211461
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-24

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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