OLANZAPINE- olanzapine tablet, film coated 
Cadila Healthcare Limited

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OLANZAPINE Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1416-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 2.5 mg

Rx only

1,000 tablets

2.5 mg label

NDC 70771-1417-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 5 mg

Rx only

1,000 tablets

5 mg label

NDC 70771-1418-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 7.5 mg

Rx only

1,000 tablets

7.5 mg label

NDC 70771-1419-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 10 mg

Rx only

1,000 tablets

10 mg label

NDC 70771-1420-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 15 mg

Rx only

1,000 tablets

15 mg label

NDC 70771-1421-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 20 mg

Rx only

1,000 tablets

20 mg label
OLANZAPINE 
olanzapine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1416
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE2.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZF28
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1416-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
2NDC:70771-1416-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
3NDC:70771-1416-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
4NDC:70771-1416-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
5NDC:70771-1416-410 in 1 CARTON01/03/2019
5NDC:70771-1416-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09045901/03/2019
OLANZAPINE 
olanzapine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1417
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZF29
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1417-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
2NDC:70771-1417-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
3NDC:70771-1417-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
4NDC:70771-1417-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
5NDC:70771-1417-410 in 1 CARTON01/03/2019
5NDC:70771-1417-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09045901/03/2019
OLANZAPINE 
olanzapine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1418
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE7.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZF30
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1418-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
2NDC:70771-1418-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
3NDC:70771-1418-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
4NDC:70771-1418-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
5NDC:70771-1418-410 in 1 CARTON01/03/2019
5NDC:70771-1418-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09045901/03/2019
OLANZAPINE 
olanzapine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1419
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CROSPOVIDONE (UNII: 2S7830E561)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code ZF31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1419-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
2NDC:70771-1419-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
3NDC:70771-1419-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
4NDC:70771-1419-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
5NDC:70771-1419-410 in 1 CARTON01/03/2019
5NDC:70771-1419-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09045901/03/2019
OLANZAPINE 
olanzapine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1420
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE15 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (ELLIPTICAL-SHAPED) Size12mm
FlavorImprint Code ZF32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1420-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
2NDC:70771-1420-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
3NDC:70771-1420-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
4NDC:70771-1420-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
5NDC:70771-1420-410 in 1 CARTON01/03/2019
5NDC:70771-1420-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09045901/03/2019
OLANZAPINE 
olanzapine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1421
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE20 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (ELLIPTICAL-SHAPED) Size14mm
FlavorImprint Code ZF33
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1421-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
2NDC:70771-1421-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
3NDC:70771-1421-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
4NDC:70771-1421-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
5NDC:70771-1421-410 in 1 CARTON01/03/2019
5NDC:70771-1421-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09045901/03/2019
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1416, 70771-1417, 70771-1418, 70771-1419, 70771-1420, 70771-1421) , MANUFACTURE(70771-1416, 70771-1417, 70771-1418, 70771-1419, 70771-1420, 70771-1421)

Revised: 7/2020
Document Id: 90997780-868c-467a-85f1-64ef6284454d
Set id: 4bfa8924-41ad-49c0-b607-0925b4032e9a
Version: 4
Effective Time: 20200717
 
Cadila Healthcare Limited