Atazanavir (Page 12 of 12)

PRINCIPAL DISPLAY PANEL

NDC 69238-1135-6

Atazanavir Capsules, 100 mg

Rx only

60 Capsules

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 69238-1136-6

Atazanavir Capsules, 150 mg

Rx only

60 Capsules

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 69238-1137-6

Atazanavir Capsules, 200 mg

Rx only

60 Capsules

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

NDC 69238-1138-3

Atazanavir Capsules, 300 mg

Rx only

30 Capsules

Amneal Pharmaceuticals LLC

1
(click image for full-size original)

ATAZANAVIR atazanavir capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1135
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATAZANAVIR SULFATE (ATAZANAVIR) ATAZANAVIR 100 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
AMMONIA
BUTYL ALCOHOL
CROSPOVIDONE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
GELATIN
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color blue (blue opaque cap — white opaque body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 1135;Amneal100mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1135-6 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209717 06/03/2020
ATAZANAVIR atazanavir capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1136
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
ALCOHOL
AMMONIA
BUTYL ALCOHOL
CROSPOVIDONE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 3
GELATIN
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color blue (blue opaque cap — powder blue opaque body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 1136;Amneal150mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1136-6 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209717 06/03/2020
ATAZANAVIR atazanavir capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1137
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
ALCOHOL
AMMONIA
BUTYL ALCOHOL
CROSPOVIDONE
FD&C BLUE NO. 1
GELATIN
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color blue (blue opaque cap — blue opaque body) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code 1137;Amneal200mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1137-6 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209717 06/03/2020
ATAZANAVIR atazanavir capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1138
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
ALCOHOL
AMMONIA
BUTYL ALCOHOL
CROSPOVIDONE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color red (red opaque cap — blue opaque body) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code 1138;Amneal300mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1138-3 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209717 06/03/2020
Labeler — Amneal Pharmaceuticals NY LLC (123797875)

Revised: 07/2021 Amneal Pharmaceuticals NY LLC

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