Labetalol HCL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Labetalol Hydrochloride.
| Product ID | 50090-1161_2dc66869-2293-4bb0-9fc1-8743bb49c884 |
| NDC | 50090-1161 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Labetalol HCL |
| Generic Name | Labetalol Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-07-24 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA200908 |
| Labeler Name | A-S Medication Solutions |
| Substance Name | LABETALOL HYDROCHLORIDE |
| Active Ingredient Strength | 100 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 | 2014-11-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA200908 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-06-04 |
| Marketing End Date | 2019-10-31 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-14 |
| Marketing Category | ANDA |
| Application Number | ANDA200908 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-11-28 |
| Marketing End Date | 2019-09-30 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-02-14 |
| Ingredient | Strength |
|---|---|
| LABETALOL HYDROCHLORIDE | 100 mg/1 |
| SPL SET ID: | 312dde0d-5147-483e-968f-4e0d46114176 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0185-0010 | Labetalol HCl | Labetalol HCl |
| 0185-0117 | Labetalol HCl | Labetalol HCl |
| 0185-0118 | Labetalol HCl | Labetalol HCl |
| 0615-8130 | Labetalol HCL | Labetalol Hydrochloride |
| 0615-8131 | Labetalol HCL | Labetalol Hydrochloride |
| 68001-204 | Labetalol HCl | Labetalol HCl |
| 68001-205 | Labetalol HCl | Labetalol HCl |
| 68001-206 | Labetalol HCl | Labetalol HCl |
| 70518-0534 | Labetalol HCl | Labetalol HCl |
| 70518-1546 | Labetalol HCL | Labetalol HCL |
| 71335-0696 | Labetalol HCl | Labetalol HCl |
| 71335-0733 | Labetalol HCl | Labetalol HCl |
| 49884-123 | Labetalol HCL | Labetalol HCL |
| 49884-122 | Labetalol HCL | Labetalol HCL |
| 49884-124 | Labetalol HCL | Labetalol HCL |
| 50090-1161 | Labetalol HCL | Labetalol HCL |
| 50090-1291 | Labetalol HCL | Labetalol HCL |
| 51079-929 | Labetalol HCl | Labetalol HCl |
| 51079-928 | Labetalol HCl | Labetalol HCl |
| 52533-034 | Labetalol HCl | Labetalol HCl |
| 55154-5485 | Labetalol HCl | Labetalol HCl |
| 60687-125 | Labetalol HCl | Labetalol HCl |
| 60687-136 | Labetalol HCl | Labetalol HCl |
| 60687-114 | Labetalol HCl | Labetalol HCl |
| 63739-366 | Labetalol HCl | Labetalol HCl |
| 60760-610 | Labetalol HCl | Labetalol HCl |
| 71335-1410 | Labetalol HCL | Labetalol HCL |
| 63629-2212 | Labetalol HCL | Labetalol HCL |
| 63629-2216 | Labetalol HCL | Labetalol HCL |
| 63629-2211 | Labetalol HCL | Labetalol HCL |
| 63629-2213 | Labetalol HCL | Labetalol HCL |
| 63629-2215 | Labetalol HCL | Labetalol HCL |
| 0143-9366 | Labetalol HCl in Dextrose | Labetalol Hydrochloride |
| 0143-9363 | Labetalol HCl in Sodium Chloride | LABETALOL HYDROCHLORIDE |
| 0143-9364 | Labetalol HCl in Sodium Chloride | LABETALOL HYDROCHLORIDE |
| 0143-9365 | Labetalol HCl in Sodium Chloride | LABETALOL HYDROCHLORIDE |
| 0143-9320 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0143-9622 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0143-9623 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0409-2267 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0409-2339 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0591-0605 | Labetalol hydrochloride | Labetalol hydrochloride |
| 0591-0606 | Labetalol hydrochloride | Labetalol hydrochloride |
| 0591-0607 | Labetalol hydrochloride | Labetalol hydrochloride |
| 0615-4539 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0615-7686 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0615-7687 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0615-7688 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0641-6252 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 0904-5928 | Labetalol hydrochloride | Labetalol hydrochloride |