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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

OLANZAPINE
olanzapine tablet, orally disintegrating

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

OLANZAPINE
olanzapine tablet, orally disintegrating

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

OLANZAPINE
olanzapine tablet, orally disintegrating

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Zydus Lifesciences Limited (918596198)

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