NDC 62332-383

Bosentan

Bosentan

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

Product ID62332-383_f958ddae-12bf-4445-b3d5-7787ef601ecc
NDC62332-383
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 Inc.
Substance NameBOSENTAN
Active Ingredient Strength63 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 62332-383-10

100 TABLET, FILM COATED in 1 CARTON (62332-383-10)
Marketing Start Date2020-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62332-383-60 [62332038360]

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

NDC 62332-383-10 [62332038310]

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

Drug Details

Active Ingredients

IngredientStrength
BOSENTAN62.5 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

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