OMEPRAZOLE DR is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Omeprazole.
| Product ID | 61919-176_4144b16e-5027-009d-e054-00144ff88e88 |
| NDC | 61919-176 |
| Product Type | Human Prescription Drug |
| Proprietary Name | OMEPRAZOLE DR |
| Generic Name | Omeprazole Dr |
| Dosage Form | Capsule, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-01-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA076048 |
| Labeler Name | Direct Rx |
| Substance Name | OMEPRAZOLE |
| Active Ingredient Strength | 20 mg/1 |
| Pharm Classes | Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2015-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA076048 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-01 |
| Marketing End Date | 2020-01-30 |
| Marketing Category | ANDA |
| Application Number | ANDA076048 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-01 |
| Marketing End Date | 2020-01-30 |
| Marketing Category | ANDA |
| Application Number | ANDA076048 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-01 |
| Marketing Category | ANDA |
| Application Number | ANDA076048 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-01 |
| Marketing End Date | 2020-01-30 |
| Marketing Category | ANDA |
| Application Number | ANDA076048 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-01 |
| Marketing End Date | 2020-01-30 |
| Marketing Category | ANDA |
| Application Number | ANDA076048 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-01 |
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE | 20 mg/1 |
| SPL SET ID: | c6bc8fb7-2862-464a-b7c9-e409034f072a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 61919-176 | OMEPRAZOLE DR | OMEPRAZOLE DR |
| 61919-773 | OMEPRAZOLE DR | OMEPRAZOLE DR |
| 61919-807 | OMEPRAZOLE DR | OMEPRAZOLE DR |
| 51655-022 | OMEPRAZOLE | OMEPRAZOLE DR |