Jatenzo (Page 6 of 6)

158 mg Bottle Label

158 mg
(click image for full-size original)

198 mg Bottle Label

198 mg
(click image for full-size original)

237 mg Bottle Label

237 mg
(click image for full-size original)
JATENZO testosterone undecanoate capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69087-158
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE UNDECANOATE (TESTOSTERONE) TESTOSTERONE UNDECANOATE 158 mg
Inactive Ingredients
Ingredient Name Strength
OLEIC ACID
POLYOXYL 40 HYDROGENATED CASTOR OIL
BORAGE OIL
PEPPERMINT OIL
BUTYLATED HYDROXYTOLUENE
GELATIN
SORBITOL
GLYCERIN
WATER
FERRIC OXIDE RED
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
Product Characteristics
Color red (red (opaque)) Score no score
Shape CAPSULE (CAPSULE) Size 21mm
Flavor Imprint Code 158
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69087-158-12 12 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the BOX (69087-158-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206089 08/01/2019
JATENZO testosterone undecanoate capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69087-198
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE UNDECANOATE (TESTOSTERONE) TESTOSTERONE UNDECANOATE 198 mg
Inactive Ingredients
Ingredient Name Strength
OLEIC ACID
POLYOXYL 40 HYDROGENATED CASTOR OIL
BORAGE OIL
PEPPERMINT OIL
BUTYLATED HYDROXYTOLUENE
GELATIN
SORBITOL
GLYCERIN
WATER
TITANIUM DIOXIDE
Product Characteristics
Color white (white (opaque)) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code 198
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69087-198-12 12 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the BOX (69087-198-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206089 08/01/2019
JATENZO testosterone undecanoate capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69087-237
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE UNDECANOATE (TESTOSTERONE) TESTOSTERONE UNDECANOATE 237 mg
Inactive Ingredients
Ingredient Name Strength
OLEIC ACID
POLYOXYL 40 HYDROGENATED CASTOR OIL
BORAGE OIL
PEPPERMINT OIL
BUTYLATED HYDROXYTOLUENE
GELATIN
SORBITOL
GLYCERIN
WATER
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
Product Characteristics
Color orange (orange (opaque)) Score no score
Shape CAPSULE (CAPSULE) Size 26mm
Flavor Imprint Code 237
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69087-237-12 12 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the BOX (69087-237-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206089 08/01/2019
Labeler — TOLMAR Inc. (791156578)

Revised: 08/2023 TOLMAR Inc.

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