ATOMOXETINE- atomoxetine capsule 
Cadila Healthcare Limited

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ATOMOXETINE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-606-16 in bottle of 90 Capsules

Atomoxetine Capsules, 18 mg

90 Capsules

Atomoxetine 18 mg

NDC 65841-607-16 in bottle of 90 Capsules

Atomoxetine Capsules, 25 mg

90 Capsules

Atomoxetine 25 mg

NDC 65841-608-16 in bottle of 90 Capsules

Atomoxetine Capsules, 40 mg

90 Capsules

Atomoxetine 40 mg

NDC 65841-609-16 in bottle of 90 Capsules

Atomoxetine Capsules, 60 mg

90 Capsules

Atomoxetine 60 mg

NDC 65841-610-16 in bottle of 90 Capsules

Atomoxetine Capsules, 80 mg

90 Capsules

Atomoxetine 80 mg

NDC 65841-611-16 in bottle of 90 Capsules

Atomoxetine Capsules, 100 mg

90 Capsules

Atomoxetine caps 100 mg
ATOMOXETINE 
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-606
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE18 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (GOLDEN) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size14mm
FlavorImprint Code ZA;68
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-606-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
2NDC:65841-606-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
3NDC:65841-606-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
4NDC:65841-606-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
5NDC:65841-606-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901712/06/2017
ATOMOXETINE 
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-607
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (OPAQUE BLUE) , WHITE (OPAQUE WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code ZA69;25mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-607-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
2NDC:65841-607-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
3NDC:65841-607-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
4NDC:65841-607-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
5NDC:65841-607-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
6NDC:65841-607-7710 in 1 CARTON12/06/2017
6NDC:65841-607-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901712/06/2017
ATOMOXETINE 
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-608
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE40 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
GELATIN (UNII: 2G86QN327L)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHELLAC (UNII: 46N107B71O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBLUE (OPAQUE BLUE) , BLUE (OPAQUE BLUE) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code ZA70;40mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-608-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
2NDC:65841-608-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
3NDC:65841-608-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
4NDC:65841-608-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
5NDC:65841-608-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
6NDC:65841-608-7710 in 1 CARTON12/06/2017
6NDC:65841-608-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901712/06/2017
ATOMOXETINE 
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-609
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE60 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (OPAQUE BLUE) , YELLOW (GOLDEN) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code ZA71;60mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-609-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
2NDC:65841-609-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
3NDC:65841-609-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
4NDC:65841-609-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
5NDC:65841-609-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
6NDC:65841-609-7710 in 1 CARTON12/06/2017
6NDC:65841-609-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901712/06/2017
ATOMOXETINE 
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-610
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE80 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (OPAQUE BROWN) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code ZA72;80mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-610-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
2NDC:65841-610-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
3NDC:65841-610-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
4NDC:65841-610-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
5NDC:65841-610-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
6NDC:65841-610-7710 in 1 CARTON12/06/2017
6NDC:65841-610-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901712/06/2017
ATOMOXETINE 
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-611
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE (UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8) ATOMOXETINE100 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBROWN (OPAQUE BROWN) , BROWN (OPAQUE BROWN) Scoreno score
ShapeCAPSULE (CAPSULE) Size21mm
FlavorImprint Code ZA73;100mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-611-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
2NDC:65841-611-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
3NDC:65841-611-022000 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
4NDC:65841-611-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
5NDC:65841-611-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901712/06/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-606, 65841-607, 65841-608, 65841-609, 65841-610, 65841-611) , MANUFACTURE(65841-606, 65841-607, 65841-608, 65841-609, 65841-610, 65841-611)

Revised: 8/2020
Document Id: fba29c64-2381-47b9-89da-6fb08ef92c81
Set id: 2e3dffc9-90f2-443c-88e5-e8a9bf1ba143
Version: 4
Effective Time: 20200813
 
Cadila Healthcare Limited