Yosprala (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 81 mg/40 mg Tablet Bottle Label

NDC 64950-424-90
90 tablets

Yosprala®
(aspirin and omeprazole)
delayed-release tablets

81 mg/40 mg tablets

Dispense with accompanying Medication Guide
Do not split, chew, crush, or dissolve the tablet.

GenusLifesciences Inc.

Rx only

PRINCIPAL DISPLAY PANEL -- 81 mg/40 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 325 mg/40 mg Tablet Bottle Label

NDC 64950-425-90
90 tablets

Yosprala®
(aspirin and omeprazole)
delayed-release tablets

325 mg/40 mg tablets

Dispense with accompanying Medication Guide
Do not split, chew, crush, or dissolve the tablet.

GenusLifesciences Inc.

Rx only

PRINCIPAL DISPLAY PANEL -- 325 mg/40 mg Tablet Bottle Label
(click image for full-size original)
YOSPRALA aspirin and omeprazole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64950-424
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aspirin (aspirin) aspirin 81 mg
omeprazole (omeprazole) omeprazole 40 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SILICON DIOXIDE
stearic acid
methacrylic acid — ethyl acrylate copolymer (1:1) type A
triethyl citrate
glyceryl monostearate
polysorbate 80
titanium dioxide
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
polydextrose
triacetin
ferric oxide yellow
FD&C blue no. 2
talc
sodium phosphate, dibasic, anhydrous
carnauba wax
POVIDONE, UNSPECIFIED
Product Characteristics
Color BLUE (blue-green) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 81;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64950-424-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64950-424-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205103 03/04/2019
YOSPRALA aspirin and omeprazole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64950-425
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
aspirin (aspirin) aspirin 325 mg
omeprazole (omeprazole) omeprazole 40 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SILICON DIOXIDE
stearic acid
methacrylic acid — ethyl acrylate copolymer (1:1) type A
triethyl citrate
glyceryl monostearate
polysorbate 80
titanium dioxide
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
polydextrose
triacetin
ferric oxide yellow
FD&C blue no. 2
talc
sodium phosphate, dibasic, anhydrous
carnauba wax
POVIDONE, UNSPECIFIED
Product Characteristics
Color BLUE (blue-green) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code 325;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64950-425-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64950-425-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205103 03/04/2019
Labeler — Genus Lifesciences Inc. (113290444)
Establishment
Name Address ID/FEI Operations
Patheon Pharmaceucticals 005286822 MANUFACTURE (64950-424), MANUFACTURE (64950-425), PACK (64950-424), PACK (64950-425), LABEL (64950-424), LABEL (64950-425)

Revised: 02/2019 Genus Lifesciences Inc.

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