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- Omeprazole OMEPRAZOLE 40 mg/1 Zydus Lifesciences Limited
Omeprazole
- Omeprazole OMEPRAZOLE 40 mg/1 NCS HealthCare of KY, LLC dba Vangard Labs
- Omeprazole OMEPRAZOLE 40 mg/1 NuCare Pharmaceuticals,Inc.
- OMEPRAZOLE OMEPRAZOLE 40 mg/1 Direct Rx
- Omeprazole OMEPRAZOLE 40 mg/1 Sandoz Inc
- Omeprazole OMEPRAZOLE 40 mg/1 A-S Medication Solutions
- Omeprazole OMEPRAZOLE 40 mg/1 Bryant Ranch Prepack
- Omeprazole OMEPRAZOLE 40 mg/1 Quality Care Products LLC
- Omeprazole DR OMEPRAZOLE 40 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
- Omeprazole OMEPRAZOLE 40 mg/1 medsource pharmaceuticals
- Omeprazole OMEPRAZOLE 40 mg/1 Aphena Pharma Solutions - Tennessee, LLC
- Omeprazole OMEPRAZOLE 40 mg/1 RPK Pharmaceuticals, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 Golden State Medical Supply, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 NuCarePharmaceuticals, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 Apotex Corp
- Omeprazole OMEPRAZOLE 40 mg/1 Aurobindo Pharma Limited
- Omeprazole OMEPRAZOLE 40 mg/1 A-S Medication Solutions
- OMEPRAZOLE DR OMEPRAZOLE 40 mg/1 Direct Rx
- Omeprazole OMEPRAZOLE 40 mg/1 Proficient Rx LP
- Omeprazole OMEPRAZOLE 40 mg/1 Northwind Pharmaceuticals, LLC
- Omeprazole OMEPRAZOLE 40 mg/1 REMEDYREPACK INC.
- Omeprazole OMEPRAZOLE 40 mg/1 Lannett Company, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 A-S Medication Solutions
- Omeprazole OMEPRAZOLE 40 mg/1 QPharma Inc
- Omeprazole OMEPRAZOLE 40 mg/1 Dr. Reddy's Laboratories Limited
- Omeprazole OMEPRAZOLE 40 mg/1 Rising Health, LLC
- Omeprazole OMEPRAZOLE 40 mg/1 Preferred Pharmaceuticals Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 Bryant Ranch Prepack
- Omeprazole OMEPRAZOLE 40 mg/1 Quallent Pharmaceuticals Health LLC
- Omeprazole OMEPRAZOLE 40 mg/1 Bryant Ranch Prepack
- Omeprazole OMEPRAZOLE 40 mg/1 PD-Rx Pharmaceuticals, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 American Health Packaging
- Omeprazole OMEPRAZOLE 40 mg/1 Proficient Rx LP
- Omeprazole OMEPRAZOLE 40 mg/1 Lake Erie Medical DBA Quality Care Products LLC
- Omeprazole OMEPRAZOLE 40 mg/1 AvPAK
- OMEPRAZOLE OMEPRAZOLE 40 mg/1 Direct Rx
- Omeprazole OMEPRAZOLE 40 mg/1 PD-Rx Pharmaceuticals, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 RPK Pharmaceuticals, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 RPK Pharmaceuticals, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 Zydus Pharmaceuticals USA Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 A-S Medication Solutions
- Omeprazole OMEPRAZOLE 40 mg/1 NorthStar Rx LLC
- Omeprazole OMEPRAZOLE 40 mg/1 Aphena Pharma Solutions - Tennessee, LLC
- Omeprazole OMEPRAZOLE 40 mg/1 NuCare Pharmaceuticals,Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 QPharma Inc
- Omeprazole OMEPRAZOLE 40 mg/1 REMEDYREPACK INC.
- Omeprazole OMEPRAZOLE 40 mg/1 PD-Rx Pharmaceuticals, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 Golden State Medical Supply, Inc.
- Omeprazole OMEPRAZOLE 40 mg/1 Zydus Lifesciences Limited
- OMEPRAZOLE DR OMEPRAZOLE 40 mg/1 Direct Rx
- Omeprazole DR OMEPRAZOLE 40 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
- Omeprazole OMEPRAZOLE 40 mg/1 Proficient Rx LP
- Omeprazole OMEPRAZOLE 40 mg/1 Glenmark Pharmaceuticals Inc., USA
Summary of product characteristics
Effective Time
20230927
Version
9
Spl Product Data Elements
Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ACETONE FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE AMETHYST PURPLE WHITE CAPSULE ZA;09;10mg Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ACETONE FD&C BLUE NO. 1 FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE TAN WHITE CAPSULE ZA;10;20mg Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ACETONE FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE AMETHYST PURPLE WHITE CAPSULE ZA;11;40mg
Application Number
ANDA091352
Brand Name
Omeprazole
Generic Name
Omeprazole
Product Ndc
65841-761
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-759-01 in bottle of 100 Capsules Omeprazole Delayed-release Capsules USP, 10 mg R x only 100 Capsules NDC 65841-760-01 in bottle of 100 Capsules Omeprazole Delayed-release Capsules USP, 20 mg R x only 100 Capsules NDC 65841-761-01 in bottle of 100 Capsules Omeprazole Delayed-release Capsules USP, 40 mg R x only 100 Capsules Omeprazole DR Capsules, 10 mg Omeprazole DR Capsules, 20 mg Omeprazole DR Capsules, 40 mg
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