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

1
(click image for full-size original)

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

1
(click image for full-size original)

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

1
(click image for full-size original)

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

1
(click image for full-size original)
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.

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