Labetalol Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Method Pharmaceuticals, Llc. The primary component is Labetalol.
| Product ID | 58657-604_c8bcb9bc-ab9b-4a72-8ec7-920e7a5f71e3 |
| NDC | 58657-604 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Labetalol Hydrochloride |
| Generic Name | Labetalol Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-11-22 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075215 |
| Labeler Name | Method Pharmaceuticals, LLC |
| 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 | 2020-12-31 |
| Marketing Start Date | 2019-11-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Ingredient | Strength |
|---|---|
| LABETALOL | 300 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0615-8130 | Labetalol HCL | Labetalol Hydrochloride |
| 0615-8131 | Labetalol HCL | Labetalol Hydrochloride |
| 49884-122 | Labetalol HCL | Labetalol Hydrochloride |
| 49884-123 | Labetalol HCL | Labetalol Hydrochloride |
| 49884-124 | Labetalol HCL | Labetalol Hydrochloride |
| 50090-1161 | Labetalol HCL | Labetalol Hydrochloride |
| 50090-1291 | Labetalol HCL | Labetalol Hydrochloride |
| 70518-1546 | Labetalol HCL | 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 |
| 0904-5928 | Labetalol hydrochloride | Labetalol hydrochloride |
| 0904-5929 | Labetalol hydrochloride | Labetalol hydrochloride |
| 0904-5930 | Labetalol hydrochloride | Labetalol hydrochloride |
| 17478-420 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 21695-592 | Labetalol hydrochloride | Labetalol hydrochloride |
| 21695-988 | Labetalol hydrochloride | Labetalol hydrochloride |
| 21695-994 | Labetalol hydrochloride | Labetalol hydrochloride |
| 24979-168 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 24979-169 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 24979-170 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 43199-037 | Labetalol Hydrochloride | labetalol hydrochloride |
| 43199-038 | Labetalol Hydrochloride | labetalol hydrochloride |
| 43199-039 | Labetalol Hydrochloride | labetalol hydrochloride |
| 47781-552 | Labetalol Hydrochloride | labetalol hydrochloride |
| 47781-553 | Labetalol Hydrochloride | labetalol hydrochloride |
| 47781-554 | Labetalol Hydrochloride | labetalol hydrochloride |
| 47781-586 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 50090-2428 | Labetalol Hydrochloride | labetalol hydrochloride |
| 50090-4149 | Labetalol Hydrochloride | labetalol hydrochloride |
| 50436-4364 | Labetalol hydrochloride | Labetalol hydrochloride |
| 50436-4365 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 51662-1228 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE |
| 51991-934 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 51991-935 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 55154-4747 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 55154-5876 | Labetalol hydrochloride | Labetalol hydrochloride |
| 55154-6877 | Labetalol hydrochloride | Labetalol hydrochloride |
| 58657-605 | Labetalol Hydrochloride | Labetalol |
| 58657-606 | Labetalol Hydrochloride | Labetalol |
| 58657-607 | Labetalol Hydrochloride | Labetalol |
| 60429-277 | Labetalol hydrochloride | Labetalol hydrochloride |
| 60429-278 | Labetalol hydrochloride | Labetalol hydrochloride |
| 60429-279 | Labetalol hydrochloride | Labetalol hydrochloride |
| 60760-231 | Labetalol Hydrochloride | labetalol hydrochloride |
| 60760-291 | Labetalol hydrochloride | Labetalol hydrochloride |
| 63629-5268 | Labetalol hydrochloride | Labetalol hydrochloride |
| 63629-5311 | Labetalol hydrochloride | Labetalol hydrochloride |
| 68001-381 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 68001-382 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 68001-383 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 68071-3180 | Labetalol Hydrochloride | labetalol hydrochloride |
| 68083-111 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 68258-6047 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 68382-798 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 68382-799 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 68382-800 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 69292-501 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 69292-502 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 69292-503 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 70518-0027 | Labetalol Hydrochloride | labetalol hydrochloride |
| 70518-1132 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 70518-1163 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 70518-1887 | Labetalol Hydrochloride | labetalol hydrochloride |
| 70771-1163 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 70771-1164 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 70771-1165 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 71205-095 | Labetalol hydrochloride | Labetalol hydrochloride |
| 71335-0118 | Labetalol Hydrochloride | labetalol hydrochloride |
| 72266-102 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 72266-103 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 72611-734 | labetalol hydrochloride | labetalol hydrochloride |
| 72611-738 | labetalol hydrochloride | labetalol hydrochloride |
| 14803-502 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 14803-503 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 14803-504 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 71209-083 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 71209-084 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 71209-085 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 71930-035 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 71930-036 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 71930-037 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 50090-3584 | Labetalol Hydrochloride | labetalol hydrochloride |
| 71335-1242 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 60687-439 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 60687-450 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 60687-461 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 58657-602 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 58657-603 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 58657-604 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 72572-350 | Labetalol Hydrochloride | Labetalol Hydrochloride |
| 65483-391 | Trandate | labetalol hydrochloride |
| 65483-392 | Trandate | labetalol hydrochloride |
| 65483-393 | Trandate | labetalol hydrochloride |