NDC 68180-387

Bosentan

Bosentan

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

Product ID68180-387_7dd72f02-4300-434a-a67c-f6ab1cff4991
NDC68180-387
Product TypeHuman Prescription Drug
Proprietary NameBosentan
Generic NameBosentan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA206987
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameBOSENTAN
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 Through2024-12-31

Packaging

NDC 68180-387-07

60 TABLET in 1 BOTTLE (68180-387-07)
Marketing Start Date2019-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-387-07 [68180038707]

Bosentan TABLET
Marketing CategoryANDA
Application NumberANDA206987
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-26

Drug Details

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.