ETODOLAC- etodolac tablet, film coated, extended release 
Cadila Healthcare Limited

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Etodolac Extended-release Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-777-14 in bottle of 60 tablets

Etodolac Extended-release Tablets USP, 400 mg

Rx only

60 tablets

Etodolac Extended-release Tablets USP, 400 mg

NDC 65841-778-14 in bottle of 60 tablets

Etodolac Extended-release Tablets USP, 500 mg

Rx only

60 tablets

Etodolac Extended-release Tablets USP, 500 mg

NDC 65841-779-14 in bottle of 60 tablets

Etodolac Extended-release Tablets USP, 600 mg

Rx only

60 tablets

Etodolac Extended-release Tablets USP, 600 mg
ETODOLAC 
etodolac tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-777
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008) ETODOLAC400 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
Product Characteristics
ColorORANGE (ORANGE) Scoreno score
ShapeOVAL (OVAL) Size17mm
FlavorImprint Code 271
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-777-1460 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
2NDC:65841-777-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
3NDC:65841-777-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
4NDC:65841-777-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
5NDC:65841-777-77100 in 1 CARTON02/15/2014
5NDC:65841-777-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113402/15/2014
ETODOLAC 
etodolac tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-778
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008) ETODOLAC500 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
Product Characteristics
ColorGRAY (GRAY) Scoreno score
ShapeOVAL (OVAL) Size18mm
FlavorImprint Code 272
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-778-1460 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
2NDC:65841-778-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
3NDC:65841-778-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
4NDC:65841-778-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
5NDC:65841-778-77100 in 1 CARTON02/15/2014
5NDC:65841-778-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113402/15/2014
ETODOLAC 
etodolac tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-779
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008) ETODOLAC600 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
Product Characteristics
ColorBLUE (BLUE) Scoreno score
ShapeOVAL (OVAL) Size19mm
FlavorImprint Code 273
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-779-1460 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
2NDC:65841-779-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
3NDC:65841-779-05500 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
4NDC:65841-779-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
5NDC:65841-779-77100 in 1 CARTON02/15/2014
5NDC:65841-779-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113402/15/2014
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-777, 65841-778, 65841-779) , MANUFACTURE(65841-777, 65841-778, 65841-779)

Revised: 7/2020
Document Id: 8781cefd-c660-42f4-9fa8-e4e076f1c4d8
Set id: 0c5f8631-f013-4bbb-b610-0a8a1311844e
Version: 5
Effective Time: 20200728
 
Cadila Healthcare Limited