INDOMETHACIN- indomethacin capsule, extended release 
Cadila Healthcare Limited

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INDOMETHACIN EXTENDED-RELEASE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1203-6

Indomethacin Extended-release Capsules, 75 mg

60 Capsules

Rx only

label
INDOMETHACIN 
indomethacin capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1203
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN75 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
SHELLAC (UNII: 46N107B71O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMMONIA (UNII: 5138Q19F1X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (DARK BLUE) , BLUE (DARK BLUE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code ZA;79;75mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1203-660 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
2NDC:70771-1203-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
3NDC:70771-1203-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
4NDC:70771-1203-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
5NDC:70771-1203-410 in 1 CARTON02/08/2018
5NDC:70771-1203-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20271102/08/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1203) , MANUFACTURE(70771-1203)

Revised: 8/2020
Document Id: b4e60945-5934-47af-8f61-d322129401be
Set id: 50bafabc-319e-4128-bc4a-7a83e7db6a90
Version: 3
Effective Time: 20200831
 
Cadila Healthcare Limited