Olanzapine Orally Disintegrating Tablets

Olanzapine by

Drug Labeling and Warnings

Olanzapine by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OLANZAPINE- olanzapine tablet, orally disintegrating 
Zydus Lifesciences Limited

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Olanzapine Orally Disintegrating Tablets

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1814-0

Olanzapine Orally Disintegrating Tablets USP, 5 mg

Rx only

1,000 tablets

NDC: 70771-1815-0

Olanzapine Orally Disintegrating Tablets USP, 10 mg

Rx only

1,000 tablets

NDC: 70771-1816-0

Olanzapine Orally Disintegrating Tablets USP, 15 mg

Rx only

1,000 tablets

NDC: 70771-1817-0

Olanzapine Orally Disintegrating Tablets USP, 20 mg

Rx only

1,000 tablets

OLANZAPINE 
olanzapine tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1814
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)	OLANZAPINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
MANNITOL (UNII: 3OWL53L36A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ORANGE (UNII: 5EVU04N5QU)
CROSPOVIDONE (UNII: 2S7830E561)

Product Characteristics
Color	YELLOW (Light Yellow toYellow)	Score	no score
Shape	ROUND (round)	Size	6mm
Flavor	ORANGE (orange)	Imprint Code	516
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1814-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
2	NDC: 70771-1814-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
3	NDC: 70771-1814-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
4	NDC: 70771-1814-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
5	NDC: 70771-1814-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202889	01/18/2025	04/29/2025

OLANZAPINE 
olanzapine tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1815
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)	OLANZAPINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
ORANGE (UNII: 5EVU04N5QU)

Product Characteristics
Color	YELLOW (Light Yellow to Yellow)	Score	no score
Shape	ROUND (round)	Size	7mm
Flavor	ORANGE (orange)	Imprint Code	517
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1815-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
2	NDC: 70771-1815-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
3	NDC: 70771-1815-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
4	NDC: 70771-1815-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
5	NDC: 70771-1815-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202889	01/18/2025	04/29/2025

OLANZAPINE 
olanzapine tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1816
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)	OLANZAPINE	15 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
ORANGE (UNII: 5EVU04N5QU)

Product Characteristics
Color	YELLOW (Light Yellow to Yellow)	Score	no score
Shape	ROUND (round)	Size	9mm
Flavor	ORANGE (orange)	Imprint Code	518
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1816-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
2	NDC: 70771-1816-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
3	NDC: 70771-1816-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
4	NDC: 70771-1816-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
5	NDC: 70771-1816-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202889	01/18/2025	04/29/2025

OLANZAPINE 
olanzapine tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1817
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR)	OLANZAPINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
ORANGE (UNII: 5EVU04N5QU)

Product Characteristics
Color	YELLOW (Light Yellow to Yellow)	Score	no score
Shape	ROUND (round)	Size	10mm
Flavor	ORANGE (orange)	Imprint Code	519
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1817-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
2	NDC: 70771-1817-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
3	NDC: 70771-1817-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
4	NDC: 70771-1817-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025
5	NDC: 70771-1817-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2025	03/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202889	01/18/2025	04/29/2025

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1814, 70771-1815, 70771-1816, 70771-1817) , MANUFACTURE(70771-1814, 70771-1815, 70771-1816, 70771-1817)

Revised: 4/2025

Document Id: e00d973a-837f-4a7b-ab1c-d19b566d55ae

34391-3

Set id: de211e8c-721b-4f8d-99cf-4607803e6b4e

Version: 4

Effective Time: 20250429