Atazanavir Sulfate (Page 12 of 12)

Package/Label Display Panel

Atazanavir Sulfate 150mg Capsules 60

NDC 51407-171-60

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Package/Label Display Panel

Atazanavir Sulfate 200mg Capsules 60

NDC 51407-172-60

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Package/Label Display Panel

Atazanavir Sulfate 300mg Capsules 30

NDC 51407-173-30

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ATAZANAVIR SULFATE atazanavir sulfate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-171(NDC:0093-5526)
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
CROSPOVIDONE (15 MPA.S AT 5%)
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SORBITAN MONOLAURATE
TITANIUM DIOXIDE
Product Characteristics
Color turquoise (light-turquoise-blue) , blue (aqua-blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code TEVA;5526
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-171-60 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091673 12/27/2017 11/30/2020
ATAZANAVIR SULFATE atazanavir sulfate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-172(NDC:0093-5527)
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
CROSPOVIDONE (15 MPA.S AT 5%)
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SORBITAN MONOLAURATE
TITANIUM DIOXIDE
Product Characteristics
Color turquoise (light-turquoise) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 93;5527;93;5527
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-172-60 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091673 12/27/2017
ATAZANAVIR SULFATE atazanavir sulfate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-173(NDC:0093-5528)
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
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SORBITAN MONOLAURATE
TITANIUM DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color blue (light-blue) , red Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code 93;5528;93;5528
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-173-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091673 12/27/2017 03/31/2022
Labeler — Golden State Medical Supply Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply Inc. 603184490 repack (51407-171), relabel (51407-172), repack (51407-172), relabel (51407-171), relabel (51407-173), repack (51407-173)

Revised: 10/2021 Golden State Medical Supply Inc.

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