NDC 68382-447

Bosentan

Bosentan

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

Product ID68382-447_041b3259-1370-4458-abef-2833886ade7e
NDC68382-447
Product TypeHuman Prescription Drug
Proprietary NameBosentan
Generic NameBosentan
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA207760
Labeler NameZydus Pharmaceuticals (USA) Inc.
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 68382-447-01

100 TABLET, COATED in 1 BOTTLE (68382-447-01)
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-447-14 [68382044714]

Bosentan TABLET, COATED
Marketing CategoryANDA
Application NumberANDA207760
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-01

NDC 68382-447-30 [68382044730]

Bosentan TABLET, COATED
Marketing CategoryANDA
Application NumberANDA207760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-01

NDC 68382-447-01 [68382044701]

Bosentan TABLET, COATED
Marketing CategoryANDA
Application NumberANDA207760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-01

NDC 68382-447-77 [68382044777]

Bosentan TABLET, COATED
Marketing CategoryANDA
Application NumberANDA207760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-01

NDC 68382-447-05 [68382044705]

Bosentan TABLET, COATED
Marketing CategoryANDA
Application NumberANDA207760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-01

NDC 68382-447-28 [68382044728]

Bosentan TABLET, COATED
Marketing CategoryANDA
Application NumberANDA207760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-01

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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