Labetalol is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Labetalol.
| Product ID | 10135-643_d283e94b-266e-40c6-bee9-856ce2d6ceb9 |
| NDC | 10135-643 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Labetalol |
| Generic Name | Labetalol |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-04-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075215 |
| Labeler Name | Marlex Pharmaceuticals Inc |
| Substance Name | LABETALOL |
| Active Ingredient Strength | 300 mg/1 |
| Pharm Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA075215 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-04-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| LABETALOL | 300 mg/1 |
| SPL SET ID: | b4c13317-88eb-48f2-aba2-50f01c8ff938 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10135-641 | Labetalol | Labetalol |
| 10135-642 | Labetalol | Labetalol |
| 10135-643 | Labetalol | Labetalol |
| 10135-711 | Labetalol Hydrochloride | Labetalol |
| 10135-712 | Labetalol Hydrochloride | Labetalol |
| 10135-713 | Labetalol Hydrochloride | Labetalol |
| 58657-605 | Labetalol Hydrochloride | Labetalol |
| 58657-606 | Labetalol Hydrochloride | Labetalol |
| 58657-607 | Labetalol Hydrochloride | Labetalol |