BOSENTAN- bosentan tablet 
Cadila Healthcare Limited

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BOSENTAN TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1017-6

Bosentan tablets, 62.5 mg

60 tablets

Rx only

Bosentan tablets

NDC 70771-1018-6

Bosentan tablets, 125 mg

60 tablets

Rx only

Bosentan tablets
BOSENTAN 
bosentan tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BOSENTAN (UNII: Q326023R30) (BOSENTAN ANHYDROUS - UNII:XUL93R30K2) BOSENTAN ANHYDROUS62.5 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorPINK (LIGHT PINK) Scoreno score
ShapeROUND (BICONVEX) Size7mm
FlavorImprint Code 446
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1017-660 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
2NDC:70771-1017-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
3NDC:70771-1017-8180 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
4NDC:70771-1017-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
5NDC:70771-1017-410 in 1 CARTON05/01/2019
5NDC:70771-1017-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776005/01/2019
BOSENTAN 
bosentan tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1018
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BOSENTAN (UNII: Q326023R30) (BOSENTAN ANHYDROUS - UNII:XUL93R30K2) BOSENTAN ANHYDROUS125 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorPINK (LIGHT PINK) Scoreno score
ShapeOVAL (BICONVEX) Size11mm
FlavorImprint Code 447
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1018-660 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
2NDC:70771-1018-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
3NDC:70771-1018-8180 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
4NDC:70771-1018-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
5NDC:70771-1018-410 in 1 CARTON05/01/2019
5NDC:70771-1018-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776005/01/2019
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1017, 70771-1018) , MANUFACTURE(70771-1017, 70771-1018)

Revised: 8/2020
Document Id: 045f6a94-0c9b-4970-b962-997b21f18375
Set id: 02892f47-0d59-4254-9ee7-d524278fdd79
Version: 3
Effective Time: 20200814
 
Cadila Healthcare Limited