ATAZANAVIR

ATAZANAVIR- atazanavir sulfate capsule
Cadila Healthcare Limited

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
(click image for full-size original)

NDC 70771-1592-6 in bottle of 60 Capsules

Atazanavir Capsules, 200 mg

Rx only

60 Capsules

200 mg label
(click image for full-size original)

NDC 70771-1593-3 in bottle of 30 Capsules

Atazanavir Capsules, 300 mg

Rx only

30 Capsules

300 mg label
(click image for full-size original)
ATAZANAVIR
atazanavir capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1591
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATAZANAVIR SULFATE (ATAZANAVIR) ATAZANAVIR 150 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
FD&C BLUE NO. 1
D&C RED NO. 28
FD&C RED NO. 40
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
WATER
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (opaque blue) , GRAY (grey opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 1050
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1591-6 60 CAPSULE in 1 BOTTLE None
2 NDC:70771-1591-1 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210575 05/04/2021
ATAZANAVIR
atazanavir capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1592
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATAZANAVIR SULFATE (ATAZANAVIR) ATAZANAVIR 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
FD&C BLUE NO. 1
D&C RED NO. 28
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
WATER
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (opaque blue) , BLUE (blue opaque) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code 1051
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1592-6 60 CAPSULE in 1 BOTTLE None
2 NDC:70771-1592-1 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210575 05/04/2021
ATAZANAVIR
atazanavir capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1593
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATAZANAVIR SULFATE (ATAZANAVIR) ATAZANAVIR 300 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN
FD&C BLUE NO. 1
D&C RED NO. 28
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
WATER
SHELLAC
AMMONIA
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color ORANGE (orange opaque) , BLUE (blue opaque) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code 1052
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1593-3 30 CAPSULE in 1 BOTTLE None
2 NDC:70771-1593-1 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210575 05/04/2021
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (863362789)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1591), ANALYSIS (70771-1592), ANALYSIS (70771-1593), MANUFACTURE (70771-1591), MANUFACTURE (70771-1592), MANUFACTURE (70771-1593)

Revised: 06/2020 Cadila Healthcare Limited

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