NDC 0591-2512

bosentan

Bosentan

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

Product ID0591-2512_5d3bd331-c167-4056-8945-d78aa08834c7
NDC0591-2512
Product TypeHuman Prescription Drug
Proprietary Namebosentan
Generic NameBosentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-06-19
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA207110
Labeler NameActavis Pharma, 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 0591-2512-60

60 TABLET, FILM COATED in 1 BOTTLE (0591-2512-60)
Marketing Start Date2019-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2512-60 [00591251260]

bosentan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207110
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-19

Drug Details

Active Ingredients

IngredientStrength
BOSENTAN125 mg/1

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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