NDC 68382-446

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 ID68382-446_041b3259-1370-4458-abef-2833886ade7e
NDC68382-446
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 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 Through2020-12-31

Packaging

NDC 68382-446-01

100 TABLET, COATED in 1 BOTTLE (68382-446-01)
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-446-14 [68382044614]

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

NDC 68382-446-28 [68382044628]

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

NDC 68382-446-05 [68382044605]

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

NDC 68382-446-30 [68382044630]

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

NDC 68382-446-77 [68382044677]

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

NDC 68382-446-01 [68382044601]

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

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

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