ROWEEPRA XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Owp Pharmaceuticals, Inc.. The primary component is Levetiracetam.
| Product ID | 69102-201_601eaa2b-5c17-74c6-e053-2991aa0a1123 |
| NDC | 69102-201 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ROWEEPRA XR |
| Generic Name | Levetiracetam |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-12-22 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202095 |
| Labeler Name | OWP Pharmaceuticals, Inc. |
| Substance Name | LEVETIRACETAM |
| Active Ingredient Strength | 750 mg/1 |
| Pharm Classes | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2018-01-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202095 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-01-30 |
| Ingredient | Strength |
|---|---|
| LEVETIRACETAM | 750 mg/1 |
| SPL SET ID: | eb66dee6-1d92-4b2d-ae4a-232faf129f24 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 69102-201 | ROWEEPRA XR | ROWEEPRA XR |
| 69102-200 | ROWEEPRA XR | ROWEEPRA XR |
| 0054-0224 | Levetiracetam | Levetiracetam |
| 0121-0799 | Levetiracetam | LEVETIRACETAM |
| 0121-1598 | Levetiracetam | LEVETIRACETAM |
| 0121-2397 | Levetiracetam | LEVETIRACETAM |
| 0121-4799 | Levetiracetam | LEVETIRACETAM |
| 0121-4802 | LEVETIRACETAM | LEVETIRACETAM |
| 0143-9574 | Levetiracetam | Levetiracetam |
| 0143-9673 | Levetiracetam | Levetiracetam |
| 0228-2167 | Levetiracetam | Levetiracetam |
| 0378-5613 | Levetiracetam | levetiracetam |
| 0378-5615 | Levetiracetam | levetiracetam |
| 0378-5617 | Levetiracetam | levetiracetam |