NDC 69097-378

BOSENTAN

Bosentan

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

Product ID69097-378_252ae260-45e5-4477-a702-830e83a16072
NDC69097-378
Product TypeHuman Prescription Drug
Proprietary NameBOSENTAN
Generic NameBosentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA210342
Labeler NameCipla 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 Through2021-12-31

Packaging

NDC 69097-378-03

60 TABLET, FILM COATED in 1 BOTTLE (69097-378-03)
Marketing Start Date2020-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-378-03 [69097037803]

BOSENTAN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-03
Inactivation Date2020-01-31
Reactivation Date2020-02-06

NDC 69097-378-76 [69097037876]

BOSENTAN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-03
Inactivation Date2020-01-31
Reactivation Date2020-02-06

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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