OMEPRAZOLE- omeprazole capsule, delayed release 
Cadila Healthcare Limited

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OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-759-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 10 mg

Rx only

100 Capsules

Omeprazole DR Capsules, 10 mg

NDC 65841-760-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 20 mg

Rx only

100 Capsules

Omeprazole DR Capsules, 20 mg

NDC 65841-761-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 40 mg

Rx only

100 Capsules

Omeprazole DR Capsules, 40 mg
OMEPRAZOLE 
omeprazole capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-759
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE10 mg
Inactive Ingredients
Ingredient NameStrength
ACETONE (UNII: 1364PS73AF)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorPURPLE (AMETHYST PURPLE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size10mm
FlavorImprint Code ZA;09;10mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-759-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
2NDC:65841-759-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
3NDC:65841-759-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
4NDC:65841-759-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
5NDC:65841-759-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135211/23/2012
OMEPRAZOLE 
omeprazole capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-760
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
ACETONE (UNII: 1364PS73AF)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorBROWN (TAN) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size11mm
FlavorImprint Code ZA;10;20mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-760-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
2NDC:65841-760-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
3NDC:65841-760-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
4NDC:65841-760-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
5NDC:65841-760-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135211/23/2012
OMEPRAZOLE 
omeprazole capsule, delayed release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-761
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE40 mg
Inactive Ingredients
Ingredient NameStrength
ACETONE (UNII: 1364PS73AF)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorPURPLE (AMETHYST PURPLE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code ZA;11;40mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-761-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
2NDC:65841-761-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
3NDC:65841-761-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
4NDC:65841-761-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
5NDC:65841-761-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135211/23/2012
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-759, 65841-760, 65841-761) , MANUFACTURE(65841-759, 65841-760, 65841-761)

Revised: 9/2020
Document Id: c2315f2b-37e0-45ac-a7ed-8181654cee5b
Set id: 2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2
Version: 7
Effective Time: 20200908
 
Cadila Healthcare Limited