Olanzapine (Page 12 of 12)

Package/Label Display Panel

NDC 0093-5245 -65

Olanzapine Orally Disintegrating Tablets, USP5 mg

Each tablet contains: olanzapine, USP 5 mg

Phenylketonurics: contains phenylalanine 1 mg per tablet.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets (5 Blister Cards Of 6 Tablets Each)

1
(click image for full-size original)

Package/Label Display Panel

NDC 0093-5246 -65

Olanzapine Orally Disintegrating Tablets, USP10 mg

Each tablet contains: olanzapine, USP 10 mg

Phenylketonurics: contains phenylalanine 2 mg per tablet.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets (5 Blister Cards Of 6 Tablets Each)

2
(click image for full-size original)

Package/Label Display Panel

NDC 0093-5247 -65

Olanzapine Orally Disintegrating Tablets, USP15 mg

Each tablet contains: olanzapine, USP 15 mg

Phenylketonurics: contains phenylalanine 3 mg per tablet.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets (5 Blister Cards Of 6 Tablets Each)

3
(click image for full-size original)

Package/Label Display Panel

NDC 0093-5248 -65

Olanzapine Orally Disintegrating Tablets, USP20 mg

Each tablet contains: olanzapine, USP 20 mg

Phenylketonurics: contains phenylalanine 4 mg per tablet.

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets (5 Blister Cards Of 6 Tablets Each)

4
(click image for full-size original)

OLANZAPINE olanzapine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5245
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SODIUM STEARYL FUMARATE
XYLITOL
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor STRAWBERRY Imprint Code TV;U1;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-5245-65 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0093-5245-19)
1 NDC:0093-5245-19 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (0093-5245-65)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077243 02/17/2012
OLANZAPINE olanzapine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5246
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SODIUM STEARYL FUMARATE
XYLITOL
Product Characteristics
Color yellow Score no score
Shape ROUND Size 9mm
Flavor STRAWBERRY Imprint Code TV;U2;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-5246-65 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0093-5246-19)
1 NDC:0093-5246-19 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (0093-5246-65)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077243 02/17/2012
OLANZAPINE olanzapine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5247
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 15 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SODIUM STEARYL FUMARATE
XYLITOL
Product Characteristics
Color yellow Score no score
Shape ROUND Size 10mm
Flavor STRAWBERRY Imprint Code TV;U7;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-5247-65 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0093-5247-19)
1 NDC:0093-5247-19 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (0093-5247-65)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077243 01/24/2012
OLANZAPINE olanzapine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5248
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 20 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
ALUMINUM OXIDE
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
XYLITOL
Product Characteristics
Color yellow Score no score
Shape ROUND Size 12mm
Flavor STRAWBERRY Imprint Code TV;U4;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-5248-65 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0093-5248-19)
1 NDC:0093-5248-19 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (0093-5248-65)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077243 01/24/2012
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 01/2022 Teva Pharmaceuticals USA, Inc.

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