OSELTAMIVIR PHOSPHATE - oseltamivir phosphate capsule 
Zydus Lifesciences Limited

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Oseltamivir Phosphate Capsules, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1710-2

OSELTAMIVIR PHOSPHATE Capsules, USP

30* mg

*Each capsule contains oseltamivir phosphate equivalent to 30 mg oseltamivir (free base).

10 Capsules

(1 x 10 Unit-Dose)

Rx only

30 mg label

NDC 70771-1711-2

OSELTAMIVIR PHOSPHATE Capsules, USP

45* mg

*Each capsule contains oseltamivir phosphate equivalent to 45 mg oseltamivir (free base).

10 Capsules

(1 x 10 Unit-Dose)

Rx only

45 mg label

NDC 70771-1712-2

OSELTAMIVIR PHOSPHATE Capsules, USP

75* mg

*Each capsule contains oseltamivir phosphate equivalent to 75 mg oseltamivir (free base).

10 Capsules

(1 x 10 Unit-Dose)

Rx only

75 mg label
OSELTAMIVIR PHOSPHATE 
oseltamivir phosphate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1710
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OSELTAMIVIR PHOSPHATE (UNII: 4A3O49NGEZ) (OSELTAMIVIR ACID - UNII:K6106LV5Q8) OSELTAMIVIR ACID30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code N;1008
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1710-21 in 1 CARTON02/24/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20857802/24/2017
OSELTAMIVIR PHOSPHATE 
oseltamivir phosphate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1711
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OSELTAMIVIR PHOSPHATE (UNII: 4A3O49NGEZ) (OSELTAMIVIR ACID - UNII:K6106LV5Q8) OSELTAMIVIR ACID45 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGRAY (Light Blue Gray) , GRAY (Light Blue Gray) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code N;1009
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1711-21 in 1 CARTON02/24/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20857802/24/2017
OSELTAMIVIR PHOSPHATE 
oseltamivir phosphate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1712
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OSELTAMIVIR PHOSPHATE (UNII: 4A3O49NGEZ) (OSELTAMIVIR ACID - UNII:K6106LV5Q8) OSELTAMIVIR ACID75 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGRAY (Light Blue Gray) , WHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code N;1010
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1712-21 in 1 CARTON02/24/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20857802/24/2017
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1710, 70771-1711, 70771-1712) , MANUFACTURE(70771-1710, 70771-1711, 70771-1712)

Revised: 10/2022
Document Id: 3564eb21-1990-45bf-a7a7-09cc7acc3e13
Set id: 58118069-cb24-4fa3-92d7-cabdc1b027f2
Version: 2
Effective Time: 20221031
 
Zydus Lifesciences Limited