OMEPRAZOLE is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Omeprazole.
| Product ID | 71610-297_3f1e716a-a86d-4096-9f15-42f9234b61c3 |
| NDC | 71610-297 |
| Product Type | Human Prescription Drug |
| Proprietary Name | OMEPRAZOLE |
| Generic Name | Omeprazole |
| Dosage Form | Capsule, Delayed Release Pellets |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-07-03 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203481 |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Substance Name | OMEPRAZOLE |
| Active Ingredient Strength | 40 mg/1 |
| Pharm Classes | Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-06-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203481 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-06-28 |
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE | 40 mg/1 |
| SPL SET ID: | d1044e87-8bd9-4c21-a1c3-12c456c52e05 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-5294 | Omeprazole | Omeprazole |
| 0363-0007 | omeprazole | Omeprazole |
| 0363-0915 | omeprazole | Omeprazole |
| 0363-1607 | Omeprazole | Omeprazole |
| 0363-1819 | omeprazole | omeprazole |
| 0363-9980 | Omeprazole | OMEPRAZOLE MAGNESIUM |
| 0378-5211 | Omeprazole | omeprazole |
| 0378-5222 | Omeprazole | omeprazole |
| 0378-6150 | Omeprazole | omeprazole |
| 0615-1359 | Omeprazole | Omeprazole |
| 0615-2302 | Omeprazole | Omeprazole |
| 0615-2305 | Omeprazole | Omeprazole |
| 0615-7933 | Omeprazole | Omeprazole |
| 0615-8079 | Omeprazole | Omeprazole |
| 0615-8320 | Omeprazole | Omeprazole |
| 0615-8406 | Omeprazole | Omeprazole |
| 0781-2234 | Omeprazole | Omeprazole |
| 68016-759 | Omeprazole | Omeprazole |
| 68071-1522 | Omeprazole | Omeprazole |
| 68071-2180 | Omeprazole | Omeprazole |
| 68071-1948 | Omeprazole | Omeprazole |
| 68071-3285 | Omeprazole | Omeprazole |
| 68071-3007 | Omeprazole | Omeprazole |
| 68071-2199 | Omeprazole | Omeprazole |
| 68071-4051 | Omeprazole | Omeprazole |
| 68071-3368 | Omeprazole | Omeprazole |
| 68071-4140 | Omeprazole | Omeprazole |
| 68071-4146 | Omeprazole | Omeprazole |
| 68071-4024 | Omeprazole | Omeprazole |
| 68071-4025 | Omeprazole | Omeprazole |
| 68084-466 | Omeprazole | Omeprazole |
| 68084-128 | Omeprazole | Omeprazole |
| 68151-3088 | Omeprazole | Omeprazole |
| 68382-411 | Omeprazole | Omeprazole |
| 68382-412 | Omeprazole | Omeprazole |
| 68382-500 | Omeprazole | Omeprazole |
| 68462-395 | Omeprazole | Omeprazole |
| 68462-396 | Omeprazole | Omeprazole |
| 68462-397 | Omeprazole | Omeprazole |
| 68788-6881 | Omeprazole | Omeprazole |
| 68788-1554 | Omeprazole | Omeprazole |
| 68788-9748 | Omeprazole | Omeprazole |
| 68788-6995 | Omeprazole | Omeprazole |
| 68788-9955 | Omeprazole | Omeprazole |
| 69181-158 | Omeprazole | Omeprazole |
| 69189-0147 | Omeprazole | Omeprazole |
| 69677-180 | Omeprazole | Omeprazole |
| 69618-047 | Omeprazole | Omeprazole |
| 69842-791 | Omeprazole | Omeprazole |
| 70518-0056 | Omeprazole | Omeprazole |