Oseltamavir Phosphate (Page 9 of 9)

Oseltamivir PO4 75mg Capsules

Label Image
(click image for full-size original)
OSELTAMAVIR PHOSPHATE oseltamavir phosphate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-3387(NDC:33342-258)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSELTAMIVIR PHOSPHATE (OSELTAMIVIR CARBOXYLATE) OSELTAMIVIR CARBOXYLATE 75 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM STEARYL FUMARATE
GELATIN, UNSPECIFIED
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:53002-3387-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (53002-3387-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207211 09/21/2017
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-3387)

Revised: 12/2020 RPK Pharmaceuticals, Inc.

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