LUMAKRAS (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 120 mg Tablet Bottle Carton Label — NDC 55513-488-02

NDC 55513-488-02

LUMAKRAS™
(sotorasib) TABLETS

120 mg

Each tablet contains 120 mg sotorasib.

Store at 20°C to 25°C (68°F to 77°F). Excursionspermitted from 15°C to 30°C (59°F to 86°F).

Recommended Dosage: See Prescribing Information.

AMGEN®

PRINCIPAL DISPLAY PANEL -- 120 mg Tablet Bottle Carton Label -- NDC 55513-488-02
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 120 mg Tablet Bottle Carton Label — NDC 55513-488-24

NDC 55513-488-24

LUMAKRAS™
(sotorasib) TABLETS

120 mg

Each tablet contains 120 mg sotorasib.

Store at 20°C to 25°C (68°F to 77°F).
Excursions permitted from 15°C to 30°C
(59°F to 86°F).

Recommended Dosage: See PrescribingInformation.

AMGEN®

PRINCIPAL DISPLAY PANEL -- 120 mg Tablet Bottle Carton Label -- NDC 55513-488-24
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 320 mg Tablet Bottle Carton Label

NDC 55513-504-50

LUMAKRAS®
(sotorasib) TABLETS

320 mg | New strength

Each tablet contains 320 mg sotorasib.

Store at 20°C to 25°C (68°F to 77°F).
Excursions permitted from 15°C to 30°C
(59°F to 86°F).

Recommended Dosage: See PrescribingInformation.

AMGEN®

PRINCIPAL DISPLAY PANEL -- 320 mg Tablet Bottle Carton Label
(click image for full-size original)
LUMAKRAS sotorasib tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-488
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOTORASIB (SOTORASIB) SOTORASIB 120 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size 16mm
Flavor Imprint Code AMG120
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55513-488-02 2 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC (55513-488-01)
1 NDC:55513-488-01 120 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55513-488-02)
2 NDC:55513-488-24 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC (55513-488-40)
2 NDC:55513-488-40 240 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55513-488-24)
3 NDC:55513-488-96 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 120 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55513-488-96)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214665 05/28/2021
LUMAKRAS sotorasib tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-504
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOTORASIB (SOTORASIB) SOTORASIB 320 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color BROWN (beige) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code AMG320
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55513-504-50 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 90 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55513-504-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214665 02/02/2023
Labeler — Amgen Inc (039976196)
Registrant — Amgen, Inc (039976196)

Revised: 10/2023 Amgen Inc

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