PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1908-8

Bosentan Tablets for Oral Suspension, 32 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Phenylketonurics: Contains Phenylalanine 2.08 mg per tablet for oral suspension.

56 Tablets (4 x 14 unit-dose)

Rx only

Zydus

BOSENTAN
bosentan tablet, for suspension

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BOSENTAN (UNII: Q326023R30) (BOSENTAN ANHYDROUS - UNII:XUL93R30K2)	BOSENTAN ANHYDROUS	32 mg

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE (off-white to pale yellow)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor	TUTTI FRUTTI	Imprint Code	1508
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1908-8	4 in 1 CARTON	02/17/2026
1	NDC:70771-1908-7	14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA213981	02/17/2026

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1908) , MANUFACTURE(70771-1908)