BISOPROLOL FUMARATE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Orit Laboratories Llc. The primary component is Bisoprolol Fumarate.
| Product ID | 15955-373_230b6ffb-0586-4e80-962c-80058c1a14bd |
| NDC | 15955-373 |
| Product Type | Human Prescription Drug |
| Proprietary Name | BISOPROLOL FUMARATE |
| Generic Name | Bisoprolol Fumarate |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-09-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204891 |
| Labeler Name | ORIT LABORATORIES LLC |
| Substance Name | BISOPROLOL FUMARATE |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-09-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204891 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-09-11 |
| Marketing Category | ANDA |
| Application Number | ANDA204891 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-09-11 |
| Ingredient | Strength |
|---|---|
| BISOPROLOL FUMARATE | 5 mg/1 |
| SPL SET ID: | 230b6ffb-0586-4e80-962c-80058c1a14bd |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-5270 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 0093-5271 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 0185-0771 | bisoprolol fumarate | bisoprolol fumarate |
| 0185-0774 | bisoprolol fumarate | bisoprolol fumarate |
| 0378-0523 | Bisoprolol Fumarate | bisoprolol fumarate |
| 0378-0524 | Bisoprolol Fumarate | bisoprolol fumarate |
| 15955-373 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE |
| 15955-374 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE |
| 16714-529 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 16714-530 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 21695-667 | Bisoprolol Fumarate | Bisoprolol fumarate |
| 21695-670 | Bisoprolol Fumarate | Bisoprolol fumarate |
| 29300-126 | Bisoprolol Fumarate | Bisoprolol fumarate |
| 29300-127 | Bisoprolol Fumarate | Bisoprolol fumarate |
| 50268-127 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 51407-645 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 51407-646 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 57237-132 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 57237-133 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 60687-679 | Bisoprolol Fumarate | Bisoprolol fumarate |
| 61919-787 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE |
| 62332-603 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE |
| 62332-604 | BISOPROLOL FUMARATE | BISOPROLOL FUMARATE |
| 63187-871 | Bisoprolol Fumarate | Bisoprolol fumarate |
| 63629-5173 | Bisoprolol Fumarate | Bisoprolol fumarate |
| 65862-086 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 68071-1582 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 68084-487 | bisoprolol fumarate | bisoprolol fumarate |
| 68151-4504 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 68788-6775 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 65862-087 | Bisoprolol Fumarate | Bisoprolol Fumarate |
| 52817-270 | Bisoprolol | Bisoprolol fumarate |
| 52817-271 | Bisoprolol | Bisoprolol fumarate |
| 63629-6907 | Bisoprolol | Bisoprolol fumarate |