Lenalidomide (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-1242-28 Rx only

Lenalidomide Capsules5 mg

WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

28 Capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-1243-28 Rx only

Lenalidomide Capsules10 mg

WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

28 Capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-1244-21 Rx only

Lenalidomide Capsules15 mg

WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

21 Capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-1246-21 Rx only

Lenalidomide Capsules25 mg

WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

21 Capsules

LENALIDOMIDE lenalidomide capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-1242 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (LENALIDOMIDE) LENALIDOMIDE 5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE GELATIN, UNSPECIFIED TITANIUM DIOXIDE FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC AMMONIA

Product Characteristics Color white Score no score Shape CAPSULE Size 18mm Flavor Imprint Code NAT;5mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0480-1242-28 28 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201452 03/03/2022

LENALIDOMIDE lenalidomide capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-1243 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (LENALIDOMIDE) LENALIDOMIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE GELATIN, UNSPECIFIED TITANIUM DIOXIDE FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC AMMONIA

Product Characteristics Color white Score no score Shape CAPSULE Size 18mm Flavor Imprint Code NAT;10mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0480-1243-28 28 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201452 03/03/2022

LENALIDOMIDE lenalidomide capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-1244 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (LENALIDOMIDE) LENALIDOMIDE 15 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE GELATIN, UNSPECIFIED TITANIUM DIOXIDE FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC AMMONIA

Product Characteristics Color white Score no score Shape CAPSULE Size 18mm Flavor Imprint Code NAT;15mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0480-1244-21 21 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201452 03/03/2022

LENALIDOMIDE lenalidomide capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-1246 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LENALIDOMIDE (LENALIDOMIDE) LENALIDOMIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE GELATIN, UNSPECIFIED TITANIUM DIOXIDE FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC AMMONIA

Product Characteristics Color white Score no score Shape CAPSULE Size 18mm Flavor Imprint Code NAT;25mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0480-1246-21 21 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201452 03/03/2022

Labeler — Teva Pharmaceuticals, Inc. (022629579)

Revised: 05/2022 Teva Pharmaceuticals, Inc.