INDOMETHACIN- indomethacin capsule 
Cadila Healthcare Limited

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INDOMETHACIN CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1004-01

Indomethacin capsules USP, 25 mg

100 Capsules

Rx only

Indomethacin Capsules, USP

NDC 70771-1005-01

Indomethacin capsules USP, 50 mg

100 Capsules

Rx only

IndomethacineCapsules, USP
INDOMETHACIN 
indomethacin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN50 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (GREEN) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 294;50mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1004-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
2NDC:70771-1004-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
3NDC:70771-1004-01000 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
4NDC:70771-1004-210 in 1 BLISTER PACK; Type 0: Not a Combination Product07/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09040307/21/2016
INDOMETHACIN 
indomethacin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN25 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (GREEN) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 293;25mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1005-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
2NDC:70771-1005-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
3NDC:70771-1005-01000 in 1 BOTTLE; Type 0: Not a Combination Product07/21/2016
4NDC:70771-1005-210 in 1 BLISTER PACK; Type 0: Not a Combination Product07/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09040307/21/2016
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1004, 70771-1005) , MANUFACTURE(70771-1004, 70771-1005)

Revised: 8/2020
Document Id: 05769859-b1ab-4c65-b441-0c17f7773634
Set id: 129eaf3a-b013-4b29-a58f-1565f9f41d5b
Version: 3
Effective Time: 20200831
 
Cadila Healthcare Limited