Oseltamavir Phosphate (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oseltamavir Phosphate Capsules USP, 30 mg
NDC: 33342-256-66
Pack count: 10 (1 x 10 Unit-dose) Capsules

oseltamivir-30mg
(click image for full-size original)

Oseltamavir Phosphate Capsules USP, 45 mg
NDC: 33342-257-66
Pack count: 10 (1 x 10 Unit-dose) Capsules
oseltamivir-45mg
(click image for full-size original)

Oseltamavir Phosphate Capsules USP, 75 mg
NDC: 33342-258-66 Pack count: 10 (1 x 10 Unit-dose) Capsules

oseltamivir-75mg
(click image for full-size original)
OSELTAMAVIR PHOSPHATE oseltamavir phosphate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-256
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSELTAMIVIR PHOSPHATE (OSELTAMIVIR ACID) OSELTAMIVIR ACID 30 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POVIDONE
STARCH, CORN
SODIUM STEARYL FUMARATE
GELATIN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
FD&C BLUE NO. 2
TALC
Product Characteristics
Color YELLOW (light yellow cap) , YELLOW (light yellow body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 30mg;M53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-256-66 01 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (33342-256-66)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207211 09/21/2017
OSELTAMAVIR PHOSPHATE oseltamavir phosphate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-257
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSELTAMIVIR PHOSPHATE (OSELTAMIVIR ACID) OSELTAMIVIR ACID 45 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POVIDONE
STARCH, CORN
SODIUM STEARYL FUMARATE
GELATIN
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
TALC
Product Characteristics
Color GRAY (grey cap) , GRAY (grey body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 45mg;M54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-257-66 01 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (33342-257-66)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207211 09/21/2017
OSELTAMAVIR PHOSPHATE oseltamavir phosphate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-258
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSELTAMIVIR PHOSPHATE (OSELTAMIVIR ACID) OSELTAMIVIR ACID 75 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POVIDONE
STARCH, CORN
SODIUM STEARYL FUMARATE
GELATIN
TITANIUM DIOXIDE
SHELLAC
PROPYLENE GLYCOL
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TALC
Product Characteristics
Color YELLOW (light yellow cap) , GRAY (grey body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 75mg;M55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33342-258-66 01 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (33342-258-66)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207211 09/21/2017
Labeler — Macleods Pharmaceuticals Limited (862128535)
Establishment
Name Address ID/FEI Operations
Macleods Pharmaceuticals Limited 676369519 ANALYSIS (33342-256), ANALYSIS (33342-257), ANALYSIS (33342-258), LABEL (33342-256), LABEL (33342-257), LABEL (33342-258), MANUFACTURE (33342-256), MANUFACTURE (33342-257), MANUFACTURE (33342-258), PACK (33342-256), PACK (33342-257), PACK (33342-258)

Revised: 09/2022 Macleods Pharmaceuticals Limited

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