ATAZANAVIR- atazanavir capsule 
Cadila Healthcare Limited

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Atazanavir Capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1591-6 in bottle of 60 Capsules

Atazanavir Capsules, 150 mg

Rx only

60 Capsules

150 mg label

NDC 70771-1592-6 in bottle of 60 Capsules

Atazanavir Capsules, 200 mg

Rx only

60 Capsules

200 mg label

NDC 70771-1593-3 in bottle of 30 Capsules

Atazanavir Capsules, 300 mg

Rx only

30 Capsules

300 mg label
ATAZANAVIR 
atazanavir capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1591
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S) ATAZANAVIR150 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
Product Characteristics
ColorBLUE (opaque blue) , GRAY (grey opaque) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 1050
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1591-660 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
2NDC:70771-1591-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21057505/04/2021
ATAZANAVIR 
atazanavir capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1592
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S) ATAZANAVIR200 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
Product Characteristics
ColorBLUE (opaque blue) , BLUE (blue opaque) Scoreno score
ShapeCAPSULESize21mm
FlavorImprint Code 1051
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1592-660 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
2NDC:70771-1592-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21057505/04/2021
ATAZANAVIR 
atazanavir capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1593
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S) ATAZANAVIR300 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorORANGE (orange opaque) , BLUE (blue opaque) Scoreno score
ShapeCAPSULESize24mm
FlavorImprint Code 1052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1593-330 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
2NDC:70771-1593-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21057505/04/2021
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1591, 70771-1592, 70771-1593) , MANUFACTURE(70771-1591, 70771-1592, 70771-1593)

Revised: 6/2020
Document Id: d8071667-c97b-449f-9ad4-551d838849e2
Set id: 59417e87-cf46-4db6-975b-daf9c921098f
Version: 1
Effective Time: 20200606
 
Cadila Healthcare Limited