NDC 65162-873

Bosentan

Bosentan

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

Product ID65162-873_1fb8b35b-4aa6-4ba0-86c1-9e9d1afe31ea
NDC65162-873
Product TypeHuman Prescription Drug
Proprietary NameBosentan
Generic NameBosentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA209742
Labeler NameAmneal Pharmaceuticals LLC
Substance NameBOSENTAN ANHYDROUS
Active Ingredient Strength63 mg/1
Pharm ClassesCytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65162-873-06

60 TABLET, FILM COATED in 1 BOTTLE (65162-873-06)
Marketing Start Date2019-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-873-06 [65162087306]

Bosentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209742
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-26

Drug Details

Active Ingredients

IngredientStrength
BOSENTAN ANHYDROUS62.5 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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