AMBRISENTAN- ambrisentan tablet, film coated 
Cadila Healthcare Limited

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AMBRISENTAN Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1363-3

Ambrisentan Tablets, 5 mg

30 Tablets

Rx only

labels

NDC 70771-1364-3

Ambrisentan Tablets, 10 mg

30 Tablets

Rx only

label
AMBRISENTAN 
ambrisentan tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1363
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMBRISENTAN (UNII: HW6NV07QEC) (AMBRISENTAN - UNII:HW6NV07QEC) AMBRISENTAN5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorPINK (PINK) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 1179
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1363-330 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
2NDC:70771-1363-990 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
3NDC:70771-1363-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
4NDC:70771-1363-83 in 1 CARTON04/12/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:70771-1363-71 in 1 CARTON04/12/2019
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21005804/12/2019
AMBRISENTAN 
ambrisentan tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1364
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMBRISENTAN (UNII: HW6NV07QEC) (AMBRISENTAN - UNII:HW6NV07QEC) AMBRISENTAN10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorWHITE (OFF WHITE) Scoreno score
ShapeOVAL (OVAL) Size10mm
FlavorImprint Code 1180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1364-330 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
2NDC:70771-1364-990 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
3NDC:70771-1364-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
4NDC:70771-1364-83 in 1 CARTON04/12/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:70771-1364-71 in 1 CARTON04/12/2019
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21005804/12/2019
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1363, 70771-1364) , MANUFACTURE(70771-1363, 70771-1364)

Revised: 8/2020
Document Id: 10090013-5561-434a-8750-d774f51c4f29
Set id: 0e3e3320-27ac-404f-9f01-3d82696e768a
Version: 7
Effective Time: 20200805
 
Cadila Healthcare Limited