Label: OMEPRAZOLE capsule, delayed release
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NDC Code(s):
65841-759-01,
65841-759-05,
65841-759-06,
65841-759-10, view more65841-759-16, 65841-760-01, 65841-760-05, 65841-760-06, 65841-760-10, 65841-760-16, 65841-761-01, 65841-761-05, 65841-761-06, 65841-761-10, 65841-761-16
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 3, 2024
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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
NDC 65841-760-01 in bottle of 100 Capsules
Omeprazole Delayed-release Capsules USP, 20 mg
Rx only
100 Capsules
NDC 65841-761-01 in bottle of 100 Capsules
Omeprazole Delayed-release Capsules USP, 40 mg
Rx only
100 Capsules
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole capsule, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-759 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 10 mg Inactive Ingredients Ingredient Name Strength 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 Color PURPLE (AMETHYST PURPLE) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 10mm Flavor Imprint Code ZA;09;10mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-759-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 2 NDC:65841-759-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 3 NDC:65841-759-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 4 NDC:65841-759-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 5 NDC:65841-759-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091352 11/23/2012 OMEPRAZOLE
omeprazole capsule, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-760 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength 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 Color BROWN (TAN) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 11mm Flavor Imprint Code ZA;10;20mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-760-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 2 NDC:65841-760-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 3 NDC:65841-760-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 4 NDC:65841-760-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 5 NDC:65841-760-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091352 11/23/2012 OMEPRAZOLE
omeprazole capsule, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-761 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 40 mg Inactive Ingredients Ingredient Name Strength 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 Color PURPLE (AMETHYST PURPLE) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code ZA;11;40mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-761-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 2 NDC:65841-761-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 3 NDC:65841-761-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 4 NDC:65841-761-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 5 NDC:65841-761-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091352 11/23/2012 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-759, 65841-760, 65841-761) , MANUFACTURE(65841-759, 65841-760, 65841-761)